Male partner antenatal attendance and HIV testing in eastern Uganda: a randomized facility-based intervention trial.

Abstract

The objective of the study was to evaluate the effect of a written invitation letter to the spouses of new antenatal clinic attendees on attendance by couples and on male partner acceptance of HIV testing at subsequent antenatal clinic visits.
The trial was conducted with 1060 new attendees from October 2009 to February 2010 in an antenatal clinic at Mbale Regional Referral Hospital, Mbale District, eastern Uganda. The intervention comprised an invitation letter delivered to the spouses of new antenatal attendees, while the control group received an information letter, a leaflet, concerning antenatal care. The primary outcome measure was the proportion of pregnant women who attended antenatal care with their male partners during a follow-up period of four weeks. Eligible pregnant women were randomly assigned to the intervention or non-intervention groups using a randomization sequence, which was computer generated utilizing a random sequence generator (RANDOM ORG) that employed a simple randomization procedure. Respondents, health workers and research assistants were masked to group assignments.
The trial was completed with 530 women enrolled in each group. Participants were analyzed as originally assigned (intention to treat). For the primary outcome, the percentage of trial participants who attended the antenatal clinic with their partners were 16.2% (86/530) and 14.2% (75/530) in the intervention and non-intervention groups, respectively (OR = 1.2; 95% CI: 0.8, 1.6). For the secondary outcome, most of the 161 male partners attended the antenatal clinic; 82 of 86 (95%) in the intervention group and 68 of 75 (91%) in the non-intervention group were tested for HIV (OR = 2.1; 95% CI: 0.6 to 7.5).
The effect of the intervention and the control on couple antenatal attendance was similar. In addition, the trial demonstrated that a simple intervention, such as a letter to the spouse, could increase couple antenatal clinic attendance by 10%. Significantly, the majority of male partners who attended the antenatal clinic accepted HIV testing. Therefore, to further evaluate this simple and cost-effective intervention method, adequately powered studies are required to assess its effectiveness in increasing partner participation in antenatal clinics and the programme for prevention of mother to child transmission of HIV.
ClinicalTrials.gov Identifier: NCT01144234.

Full text

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RESEARCHOpen Access
Male partner antenatal attendance and HIV
testing in eastern Uganda: a randomized
facility-based intervention trial
Robert Byamugisha1,5*, Anne N Åstrøm2, Grace Ndeezi3, Charles AS Karamagi4,5, Thorkild Tylleskär5and
James K Tumwine3
Abstract
Background: The objective of the study was to evaluate the effect of a written invitation letter to the spouses of
new antenatal clinic attendees on attendance by couples and on male partner acceptance of HIV testing at
subsequent antenatal clinic visits.
Methods: The trial was conducted with 1060 new attendees from October 2009 to February 2010 in an antenatal
clinic at Mbale Regional Referral Hospital, Mbale District, eastern Uganda. The intervention comprised an invitation
letter delivered to the spouses of new antenatal attendees, while the control group received an information letter,
a leaflet, concerning antenatal care. The primary outcome measure was the proportion of pregnant women who
attended antenatal care with their male partners during a follow-up period of four weeks. Eligible pregnant
women were randomly assigned to the intervention or non-intervention groups using a randomization sequence,
which was computer generated utilizing a random sequence generator (RANDOM ORG) that employed a simple
randomization procedure. Respondents, health workers and research assistants were masked to group assignments.
Results: The trial was completed with 530 women enrolled in each group. Participants were analyzed as originally
assigned (intention to treat). For the primary outcome, the percentage of trial participants who attended the
antenatal clinic with their partners were 16.2% (86/530) and 14.2% (75/530) in the intervention and non-
intervention groups, respectively (OR = 1.2; 95% CI: 0.8, 1.6). For the secondary outcome, most of the 161 male
partners attended the antenatal clinic; 82 of 86 (95%) in the intervention group and 68 of 75 (91%) in the non-
intervention group were tested for HIV (OR = 2.1; 95% CI: 0.6 to 7.5).
Conclusions: The effect of the intervention and the control on couple antenatal attendance was similar. In
addition, the trial demonstrated that a simple intervention, such as a letter to the spouse, could increase couple
antenatal clinic attendance by 10%. Significantly, the majority of male partners who attended the antenatal clinic
accepted HIV testing. Therefore, to further evaluate this simple and cost-effective intervention method, adequately
powered studies are required to assess its effectiveness in increasing partner participation in antenatal clinics and
the programme for prevention of mother to child transmission of HIV.
Trial Registration: ClinicalTrials.gov Identifier: NCT01144234.
* Correspondence: byamugishar@yahoo.co.uk
1Department of Obstetrics and Gynaecology, Mbale Regional Referral
Hospital, PO Box 921, Mbale, Uganda
Full list of author information is available at the end of the article
Byamugisha et al. Journal of the International AIDS Society 2011, 14:43
http://www.jiasociety.org/content/14/1/43
© 2011 Byamugisha et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.

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Background
Approximately 370,000 children were newly infected
with HIV during 2009 through mother to child trans-
mission [1]. Sub-Saharan Africa, the region most
affected by HIV, accounts for 67% of HIV infections
worldwide and 91% of new infections among children
[2]. HIV counselling and testing is the access point to
HIV prevention, care and treatment programmes. How-
ever, access to services for preventing mother to child
transmission of HIV in low- and middle-income coun-
tries remains limited, with only 26% of pregnant women
in such countries receiving HIV tests during 2009 [1].
Following World Health Organization (WHO) recom-
mendations [3], routine antenatal counselling and test-
ing for HIV has been introduced into prevention of
mother to child transmission (PMTCT) of HIV pro-
grammes in resource-limited settings; this has increased
HIV testing rates among antenatal attendees in several
sub-Saharan countries [4-10]. Engaging men as partners
is a critical component of the PMTCT programme, but
their involvement in antenatal care (ANC) and PMTCT
services has remained low [11-15]. However, men exer-
cise a huge influence on their wives regarding sexual
and reproductive health issues [16,17]. Male involve-
ment in antenatal HIV counselling and testing increases
the use of PMTCT interventions in resource-limited set-
tings [18-21] and is associated with reduced mother to
child transmission of HIV-1 and reduced infant mortal-
ity [22].
In Uganda, HIV is a major public health problem and
there was an estimated adult HIV prevalence rate of
6.7% in 2006 [23], yet only 15% of adults know their
HIV status. The PMTCT programme was launched in
Uganda in 2001 and is currently integrated into main-
stream antenatal care services. However, the proportion
of male partners of pregnant women tested in antenatal
clinics for HIV is low. Further, the proportion of HIV
discordance among couples who test is high, ranging
from 35% to 50% [23-26]. One objective of the Uganda’s
policy change from antenatal voluntary counselling and
testing (VCT) to routine antenatal counselling and test-
ing in June 2006 was to increase the proportion of male
partners of pregnant women offered HIV counselling
and testing services from the PMTCT programme from
3% to 25% by 2010 [27].
A study in Mbale Regional Referral Hospital in Mbale
District, eastern Uganda, revealed high antenatal HIV
testing rates (more than 90%) among pregnant women
[5] as a result of routine antenatal counselling and test-
ing. Nonetheless, antenatal attendance and HIV testing
among their male partners remained very low (4.7%)
[28] despite the fact that counsellors encouraged the
antenatal attendees to invite their male partners for
clinic attendance and HIV testing [29]. However, mea-
sures to increase male partner participation in PMTCT
programmes in Uganda have not been investigated.
Therefore, this trial was conducted to evaluate the effect
of a written invitation letter delivered to the spouses of
women attending their first antenatal visit on couple
attendance and partner acceptance of HIV testing at
subsequent antenatal clinic appointments within a four-
week follow-up period.
Methods
A randomized, parallel group, health facility-based inter-
vention trial was conducted among 1060 new attendees
(530 individuals in the intervention group and 530 in
the control group) at the antenatal clinic in Mbale
Regional Referral Hospital from October 2009 to Febru-
ary 2010. The trial setting has been described elsewhere
[29]. Routine HIV counselling and testing were carried
out according to the Uganda Ministry of Health guide-
lines (2006) [27].
A sequential HIV testing algorithm with same-day
results, which includes three rapid tests, is carried out
using one blood sample: Determine HIV 1 ⁄ 2 assay
(Abbott Laboratories, Abbott Park, IL, USA) for first
screening; STAT-PAK HIV 1 ⁄ 2 dipstick assay (Chembio
Diagnostic Systems Inc.) as a second test; and Uni-Gold
Recombigen HIV (Trinity Biotech, Wicklow, Ireland) as a
“tie-breaker”. An ANC attendee is classified as unin-
fected if Determine is negative and as HIV infected if
the Determine and STAT-PAK tests are positive. Discor-
dant Determine and STAT-PAK blood samples are
further tested using the Uni-Gold test. The HIV test
result is reported as positive if the Uni-Gold test is posi-
tive and as negative if the STAT-PAK and Uni-Gold
tests are negative.
Since 2006, ANC clinic attendees who are HIV-posi-
tive undergo CD4 cell counts before being administered
appropriate treatments according to the national
PMTCT guidelines [27]. The sample size for this trial
was calculated using a computer programme, OpenEpi,
version 2 (http://www.openepi.com/SampleSize/SSCo-
hort.htm). Based on the assumptions that antenatal cou-
ple attendance and HIV testing would increase from
4.5% (without intervention) to 9% (with intervention)
with 80% power and 95% confidence intervals, 1060 new
antenatal attendees, 530 in each group, were enrolled
into the trial. The trial was completed four weeks after
enrolment of the last participant.
Eligible trial participants were new attendees, aged 15
years or above, who agreed to attend subsequent
antenatal visit(s) within the four-week follow-up period
at Mbale Hospital, and were willing to give the invita-
tion and information letters to their male partners.
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A male partner was defined in this trial as the male who
impregnated the antenatal attendee in the current preg-
nancy. The exclusion criteria included women who
attended with their spouses at the first antenatal visit or
did not consent to participate in the trial, or had
spouses who were inaccessible.
Women attending without spouses at the first antena-
tal visit were identified at reception in the antenatal
clinic. They were tracked until they had undergone all
the standard clinic procedures (namely registration,
health education, pre- and post-test counselling for HIV,
HIV testing, obstetric examination and treatment). Indi-
viduals were approached by research assistants and
informed about the trial’s objective and the intervention.
Those who agreed to participate in the trial by providing
written consent were enrolled into the trial using an
enrolment form with a randomly generated identifica-
tion number.
Each woman was provided with a letter addressed to
her spouse and given an appointment for a return visit
two weeks later. If the participant was not able to attend
with her partner on the scheduled visit, she was given
another appointment for a return visit two weeks later.
Their identification numbers were marked on their
antenatal cards to aid follow up at the next clinic visit.
The importance of adhering to their ANC visits was
uniformly emphasized. Women who did not return to
the antenatal clinic for their scheduled visits during the
four-week follow-up period were classified as “lost to
follow up”.
At enrolment into the trial by the research assistants,
participants were randomly assigned to two parallel
groups, the intervention and non-intervention groups,
with an allocation ratio of 1:1. The intervention com-
prised an invitation letter addressed to the male partner
of the woman attending her first ANC visit, requesting
him to accompany her on the next ANC visit. The com-
parative arm (non-intervention group) received a letter
containing information concerning services offered in
the antenatal clinic at Mbale Regional Referral Hospital.
Detailed in the invitation letter was the following
information: the appointment date of the woman’s next
antenatal visit; that the antenatal and PMTCT services
are free (no user charges); that these services are benefi-
cial to the couple and their unborn baby, and that their
utilization by men is low; that he was cordially invited
to accompany the woman at her next scheduled antena-
tal visit to discuss important issues concerning her
antenatal care; and that the time spent in hospital
would be minimal.
The information letter, the leaflet, contained details
concerning services provided in the antenatal clinic, and
these included checking the woman’s blood pressure to
detect and manage high blood pressure during
pregnancy. It explained that the woman’s urine is tested
for protein, sugar and infections, that her blood is
checked for low haemoglobin levels, and that her abdo-
men is examined to investigate the wellbeing of the
baby. Lastly, the leaflet informed the woman and her
partner that PMTCT services in the clinic were free of
charge. The letters were of similar length, and content
was comparable, with one being an invitation and the
other being an information leaflet only. Each letter was
duly signed by the principal investigator.
The random allocation list of the identification num-
bers was randomly generated by an independent statisti-
cianfrom TASO Uganda
Organisation). A random sequence generator (computer
programme) at the RANDOM.ORG website [30], which
employed a simple randomization procedure, was uti-
lized. The random numbers were hand-written at the
bottom of the back page of the letters for the interven-
tion and non-intervention groups by the principal inves-
tigator. Each letter was inserted into an opaque
envelope and sealed with adhesive glue to ensure that
participants would not open their husbands’ letters.
The corresponding randomization number was written
on the back of the envelope. No antenatal clinic staff,
co-investigators, research assistants or pregnant women
knew whether the sealed envelopes contained the inter-
vention or non-intervention letters. The randomization
code was kept securely by the principal investigator.
Each woman enrolled into the trial by the research
assistants was given an identification number (serial
number). The appropriate envelope, whose randomiza-
tion number corresponded to the serial number, was
selected and given to the participant to give to her
spouse. The randomization code was revealed to the co-
investigators during data analysis.
Data were collected by five trained research assistants
using a standardized, pre-tested questionnaire, adminis-
tered to participants in English or Lumasaba (local lan-
guage) during exit interviews at subsequent clinic visits
during the four-week follow-up period. Four weeks after
enrolment into the trial, women who had not returned
for their subsequent antenatal visits were deemed to
have been lost to follow up. The research assistants
were knowledgeable in the local language and interview
techniques, and had been trained in terms of the trial
objectives and methods.
The structured interview covered topics concerning
the participant’s education, occupation, religion, ethnic
group, number of pregnancies, household assets, opi-
nions and experiences relating to routine HIV counsel-
ling and HIV testing in the antenatal clinic, and
knowledge of mother to child transmission of HIV and
infant feeding options for HIV-infected mothers.
Furthermore, her partner’s age, occupation and
(The AIDSSupport
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education was discussed. Participants were asked about
partner clinic attendance and partner antenatal HIV
testing acceptance. Questionnaires were checked for
completeness at the end of each day by the principal
investigator and clarification sought from research assis-
tants when queries arose. Data were entered using Epi-
Data version 3.1 [31] by two data entry clerks and were
validated by the principal investigator. The data file was
exported to PASW Statistics 18 [32] (formerly SPSS) for
analysis.
Ethical clearance to conduct the trial was obtained
from the Research and Ethics Committee of the School
of Medicine, Makerere University, and from the Uganda
National Council of Science and Technology. Permission
to conduct the trial in the antenatal clinic was obtained
from the Mbale Regional Referral Hospital administra-
tion through the local institutional review board. Writ-
ten informed consent was provided by all trial
participants. The trial was registered with the Clinical-
Trials.gov registry (Identifier: NCT01144234).
The pre-specified primary outcome measure of the
trial was the proportion of pregnant women who
attended ANC with their partners at the subsequent
antenatal visit. The secondary outcome measure was the
proportion of men who accepted routine antenatal HIV
testing. All participants were included in the analysis for
the primary outcome measure in the groups to which
they were originally assigned (intention to treat); analysis
for the secondary outcome included only participants
who attended their scheduled return clinic visits during
the follow-up period (per protocol analysis).
The socio-demographic characteristics of the trial par-
ticipants in the intervention and non-intervention
groups were compared using independent sample t-test
for continuous variables and the Pearson chi-square test
for categorical variables. Correlates of couple ANC
attendance (male antenatal clinic attendance) and male
partner antenatal HIV-testing in the intervention and
non-intervention groups was determined using the Pear-
son Chi-square test and the independent t-test. Multi-
collinearity among the independent variables and out-
liers were investigated. Interactions were explored and
binary logistic regression was used to test for confound-
ing variables.
All variables that were significant at the level of p <
0.2 in binary analysis, and the age of participants, were
retained in the multivariate regression model. All p
values were two-tailed at a significance level of 5%. As
indicators of model appropriateness, the goodness-of-fit
test (Omnibus Tests of Model Coefficients) of each the
final models for male partner antenatal attendance and
for partner antenatal HIV-testing in the trial groups was
significant (p < 0.05), and the Hosmer and Lemeshow
goodness-of-fit test was not significant (p value > 0.05)
(see tables 1 and 2).
Results
Trial population and follow up
A total of 1060 new antenatal attendees were enrolled
and randomly assigned to the intervention and
non-intervention groups (530 women in each group)
(Figure 1). Of these, 290 and 310 pregnant women in
the intervention and non-intervention groups, respec-
tively, attended the subsequent two antenatal visits as
scheduled; response rates were 55% (290/530) for the
intervention group and 58% (310/530) for the non-inter-
vention group. No major differences in the socio-demo-
graphic characteristics of the trial participants were
recorded between the groups (Table 3).
Analysis by intention to treat demonstrated that the
proportions of participants who attended with their
partners were 16.2% (86/530) and 14.2% (75/530) in the
intervention and non-intervention groups, respectively
(Odds Ratio, OR = 1.2; 95% Confidence Interval, CI: 0.8
to 1.6) (see Table 4). There was no difference between
the intervention and control groups with respect to the
main outcome variable using bivariate analysis [Pearson
chi-square value (c2) = 0.35, p-value = 0.55]. The major-
ity of male partners in the intervention group (95%) and
non-intervention group (91%), who attended the antena-
tal clinic with their spouses, accepted HIV testing.
There was no statistically significant difference between
the intervention and non-intervention groups with
respect to male partner antenatal HIV testing using
bivariate analysis (OR = 2.1; 95% CI: 0.6 to 7.5) and
multivariate analysis (OR = 1.6; 95% CI: 0.4 to 6.8),
table 4. The men in the two groups were similar (p-
value = 0.39).
The majority of male partners (93%, 150 out of 161)
in both trial arms who accepted antenatal HIV counsel-
ling and testing were HIV sero-negative. Three men in
the intervention group tested positive for HIV (Table 4).
All the female antenatal attendees who participated in
the trial accepted antenatal HIV testing. Twenty-five (11
in the intervention group and 14 in the control group)
tested positive for HIV (Table 4). Significantly, the male
partners of most of these HIV-positive women (84%; 21/
25) were not tested for HIV in the antenatal clinic (10
men did not attend the clinic; 11 men attended, but
declined to be tested). Of the five couples with known
HIV test results, three were discordant: in one couple,
the woman was HIV negative and male partner was
HIV positive; in two couples, the women were HIV
positive and the partners were HIV negative. Two cou-
ples were concordant (both partners had HIV-positive
test results). Therefore, in this trial, of the 150 couples
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who accepted antenatal HIV testing, 2% (three of 150)
were identified as HIV sero-discordant.
Correlates of couple antenatal attendance and male
partner antenatal HIV testing
Using multivariate logistic regression analysis, partici-
pants having asked for their partner’s permission to test
for HIV was the only variable significantly associated
with couple antenatal attendance in the intervention
group [adjusted OR (AOR) = 1.9; 95% CI: 1.1 to 3.3]
and the comparative group (AOR = 1.8; 95% CI: 1.0 to
3.2) (see Table 1). The likelihood of partner antenatal
attendance increased if the partner had completed pri-
mary school education (AOR = 1.7; 95% CI: 0.8 to 3.8),
but this association was not statistically significant.
The trial demonstrated that the likelihood of male
partner HIV testing increased if the participant had
asked their partner for permission to test for HIV, and
Table 1 Correlates of couple antenatal attendance among 600 pregnant women at Mbale Regional Referral Hospital
Study participants’
characteristics (Variables)a
intervention group (N = 290)b
Male partner antenatal clinic attendance in Male partner antenatal clinic attendance in non-
intervention group (N = 310)c
Attended
n (%)
Did not
attend
n (%)
Unadjusted
ORd(95% CI)
Adjusted OR
(95% CIe)
Attended
n (%)
Did not
attend
n (%)
Unadjusted OR
(95% CI)
Adjusted OR
(95% CI
Age (years)
15-24
25 or more
Education level
No or incomplete primary
Completed primary
Occupation
Not salaried
Salaried
Ethnic group
Bagisu
Non-Bagisu
Religion
Muslim
Christian
Asked partner permission to test
for HIV
No
Yes
Partner’s age (years)
19-29
30 or more
Partner’s occupation
Not salaried
Salaried
Partner’s education level
42 (28)
44 (32)
111 (72)
93 (68)
1
1.3 (0.8-2.1)
1
1.2 (0.7-2.1)
40 (24)
30 (25)
130 (77)
105 (75)
1
1.1 (0.6-1.8)
1
1.0 (0.6-1.8)
34 (28)
52 (31)
86 (72)
118 (69)
1
1.1 (0.7-1.9)
28 (24)
47 (24)
88 (76)
147 (76)
1
1.0 (0.6-1.7)
47 (30)
39 (29)
109 (70)
95 (71)
1
1.0 (0.6-1.6)
59 (22)
16 (36)
207 (78)
28 (64)
1
2.0 (1.0-4.0)
1
1.5 (0.7-3.2)
55 (30)
31 (29)
128 (70)
76 (71)
1
0.9 (0.6-1.6)
41 (21)
34 (29)
151 (79)
84 (71)
1
1.5 (0.9-2.5)
1
1.6 (0.9-2.9)
30 (24)
56 (34)
93 (76)
111 (67)
1
1.6 (0.9-2.6)
1
1.6 (0.9-2.6)
29 (23)
46 (25)
97 (77)
138 (75)
1
1.1 (0.7-1.9)
27 (22)
59 (35)
95 (78)
109 (65)
1
1.9 (1.1-3.2)f
1
1.9 (1.1-3.3)f
24 (17)
51 (31)
119 (83)
116 (69)
1
2.2 (1.3-3.8)g
1
1.8 (1.0-3.2)f
28 (29)
49 (37)
68 (71)
82 (63)
1
1.5 (0.8-2.6)
27 (26)
32 (26)
76 (74)
92 (74)
1
1.0 (0.3-1.8)
47 (30)
39 (29)
109 (70)
95 (71)
1
1.0 (0.6-1.6)
34 (20)
41 (29)
134 (80)
101 (71)
1
1.6 (1.0-2.7)
1
1.4 (0.8-2.5)
No or incomplete primary
Completed primary
16 (27)
62 (32)
43 (73)
133 (68)
1
1.3 (0.7-2.4)
9 (16)
59 (29)
47 (84)
147 (71)
1
2.1 (1.0-4.5)
1
1.7 (0.8-3.8)
aOther variables not statistically significant in univariate analysis were: Participant’s place of residence, marital status and total number of pregnancies. Age as a
possible confounder and all variables that were significant at the level of p < 0.2 in univariate analysis were retained in the multivariate regression model.
Multicollinearity and interaction among the independent variables, and outliers were checked for.
bThe goodness-of-fit test (Omnibus tests of Coefficients) of the final logistic regression model in the intervention group was significant [Chi-square statistic (c2) =
9.376, degrees of freedom (df) = 3, p = 0.025] and Hosmer and Lemeshow goodness of fit test was not significant [c2= 2.785, df = 6, p = 0.835] as indicators of
model appropriateness.
cFor the non-intervention group, the goodness-of-fit test (Omnibus tests of Coefficients) of the final logistic regression model was significant [c2= 13.018, df = 6,
p = 0.043] and Hosmer and Lemeshow goodness of fit test was not significant [c2= 5.617, df = 8, p = 0.690 as indicators of model appropriateness.
dOR: odds ratio
eCI: confidence interval
fStatistically significant: p < 0.05 (two-tailed)
gStatistically significant: p < 0.01(two-tailed)
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this was the case for the intervention (AOR = 2.0; 95%
CI: 1.2 to 3.5) and non-intervention groups (AOR = 1.9;
95% CI: 1.0 to 3.6). In addition, the participant being a
Christian (AOR = 1.7; 95% CI: 1.0 to 3.0) and their part-
ner being salaried (AOR = 1.8; 95% CI: 1.0 to 3.3) were
significantly associated with male partner acceptance of
antenatal HIV testing (Table 2).
Discussion
As far as we are aware, this is the second randomized
clinical trial to evaluate the effects of a written invitation
letter to spouses of antenatal attendees on partner
antenatal clinic attendance in sub-Saharan Africa. The
effect of the intervention (invitation letter) and the con-
trol (information leaflet) on couple antenatal attendance
Table 2 Correlates of male partner HIV testing in the antenatal clinic at Mbale Regional Referral Hospital, eastern
Uganda
Study participants’
characteristics (variables)a
group (N = 290)b
Male HIV testing in antenatal clinic in interventionMale HIV testing in antenatal clinic in non-
intervention group (N = 310)c
Tested
for HIV
n (%)
Not tested
for HIV
n (%)
Unadjusted
ORd(95% CI)
Adjusted OR
(95% CIe)
Tested
for HIV
n (%)
Not tested
for HIV
n (%)
Unadjusted
OR (95% CI)
Adjusted OR
(95% CI)
Age (Years)
5-24
25 or more
Education level
No or Incomplete
primary
Completed Primary
Occupation
Not salaried
Salaried
Ethnic group
Bagisu
Non-Bagisu
Religion
Muslim
Christian
Asked partner permission to
test for HIV
No
Yes
Partner’s age (years)
19-29
30 or more
Partner’s occupation
Not salaried
Salaried
Partner’s education level
No or incomplete
primary
Completed primary
40 (26)
42 (31)
113 (74)
95 (69)
1
1.2 (0.7-2.1)
1
1.2 (0.7-2.1)
33 (19)
35 (25)
137 (81)
105 (75)
1
1.4 (0.8-2.4)
1
1.3 (0.7-2.3)
33 (28)87 (72)123 (20)93 (80)1
49 (29)121 (71)1.0 (0.9-1.2)45 (23)149 (77)1.2 (0.7-2.1)
72 (28)
10 (33)
188 (72)
20 (67)
1
1.3 (0.6-2.9)
53 (20)
15 (34)
213 (80)
29 (66)
1
2.1 (1.0-4.2)
1
1.4 (0.6-3.1)
52 (28)
30 (28)
131 (72)
77 (72)
1
1.0 (0.6-1.7)
37 (19)
31 (26)
155 (81)
87 (74)
1
1.5 (0.9-2.6)
1
1.6 (0.9-2.9)
27 (22)
55 (33)
96 (78)
112 (67)
1
1.7 (1.0-3.0)f
1
1.7 (1.0-3.0)f
25 (20)
43 (23)
101 (80)
141 (77)
1
1.2 (0.7-2.1)
25 (21)
57 (34)
97 (79)
111 (66)
1
2.0 (1.2-3.4)g
1
2.0 (1.2-3.5)f
21 (15)
47 (28)
122 (85)
120 (72)
1
2.3 (1.3-4.0)g
1
1.9 (1.0-3.6)f
26 (27)
47 (36)
70 (73)
84 (64)
1
1.5 (0.8-2.7)
22 (21)
31 (25)
81 (79)
93 (75)
1
1.2 (0.7-2.3)
45 (29)
37 (28)
111 (71)
97 (72)
1
0.9 (0.6-1.6)
28 (17)
40 (28)
140 (83)
102 (72)
1
2.0 (1.1-3.4)f
1
1.8 (1.0-3.3)f
16 (27)43 (73)1 9 (16) 47 (84)11
58 (30) 137 (70)1.1 (0.6-2.2)53 (26) 153 (74)1.8 (0.8-3.9)1.5 (0.7-3.4)
aOther variables not significant in univariate analysis were: participant’s place of residence, marital status, and total number of pregnancies. Age as a possible
confounder and all variables that were significant at the level of p < 0.2 in univariate analysis were retained in the multivariate regression model.
Multicollinearity and interaction among the independent variables, and outliers were checked for.
bThe goodness-of-fit test (Omnibus tests of Coefficients) of the final logistic regression model in the intervention group was significant [chi-square statistic (c2) =
11.362, degrees of freedom (df) = 3, p = 0.010] and Hosmer and Lemeshow goodness-of-fit test was not significant [c2= 3.585, df = 6, p = 0.733] as indicators of
model appropriateness.
cFor the non-intervention group, the goodness-of-fit test (Omnibus tests of Coefficients) of the final logistic regression model was significant [c2= 15.412, df = 6,
p = 0.017] and Hosmer and Lemeshow goodness-of-fit test was not significant [c2= 8.774, df = 8, p = 0.362 as indicators of model appropriateness.
dOR: odds ratio
eCI: confidence interval
fStatistically significant: p < 0.05 (two-tailed)
gStatistically significant: p < 0.01 (two-tailed)
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in the trial was similar. The invitation letter and the
information leaflet increased couple attendance at the
antenatal clinic from approximately 5% [28] to 16% and
14%, respectively. A simple intervention letter to the
spouse could increase couple attendance by 10%. This
cost-effective intervention could be implemented in
almost all African ANC clinics with PMTCT.
The surprisingly equal effect in both arms of the trial
could be because the invitation letter (intervention) and
the information letter (control) had an official connota-
tion and were perceived by the male partners to be
credible as they originated from hospital. Therefore,
these letters influenced male antenatal attendance deci-
sions in similar ways, irrespective of the detailed
content.
A recent study, carried out in northern Uganda, has
documented that the likelihood of male partner antena-
tal attendance was increased if men were knowledgeable
about antenatal care services and if they obtained health
information from health workers [33]. The lack of any
significant difference between the intervention and the
control letter on couple antenatal attendance could be
explained by the low power of the trial as a result of the
high loss to follow up of trial participants.
The level of male antenatal attendance in this trial is
higher than one carried out in northern Tanzania [11],
but lower than those documented in studies from north-
ern Uganda [33], central Kenya [22] and Khayelitsha,
South Africa [34]. The age groups of the men in these
studies were comparable with those of the male partners
Assessed for eligibility:
1083
Enrolled/randomized:
1060
Allocated to intervention group:
530
Allocated to non-intervention group:
530
Excluded (n=23)
- Declined to participate: 4
- Husband far away: 12
- Husband too busy: 3
- Husband fears testing for HIV: 4
Analyzed per protocol for secondary
outcome:
310
Analyzed per protocol for secondary
outcome:
290
Analyzed by intention to treat for
primary outcome:
530
Analyzed by intention to treat for primary
outcome:
530
Lost to follow up: did not
return on subsequent
antenatal visit (s) within the
4-week follow-up period: 240
Lost to follow up: did not
return on subsequent
antenatal visit (s) within the
4-week follow-up period: 220
Figure 1 Trial profile.
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in the current trial. It was also reported in the northern
Uganda study that the likelihood of male antenatal
attendance was higher if men had attained secondary or
higher level education [33], but partner education level
was not significantly associated with male antenatal
attendance in the current trial. The level of partner
attendance in this trial was similar to that reported in a
study in Nairobi, Kenya [35].
Significantly, the current trial demonstrated that the
majority (more than 90%) of male partners who
attended the antenatal clinic accepted HIV counselling
and testing for HIV. A similar finding has been reported
in other studies in the region [22,35]. The implication of
this finding is that increasing male antenatal clinic
attendance is vital for involving spouses of antenatal
attendees in the PMTCT programme. A woman having
sought a partner’s permission for HIV testing was signif-
icantly associated with partner antenatal attendance and
HIV testing, as demonstrated using multivariate analysis.
A similar finding was reported in the Nairobi antenatal
clinic study [35]. This suggests that improved communi-
cation between couples regarding HIV is an important
factor in increasing the number of men accompanying
their spouses to antenatal clinics and accessing HIV
counselling and testing services.
However, there was a differential effect because the
HIV sero-status of approximately 80% of the HIV-posi-
tive women’s partners remained unknown, which consti-
tutes a missed opportunity to investigate couple HIV
sero-discordance and a failure of the intervention to
reach the intended recipients.
The trial demonstrated that at least 2% of the couples
were HIV sero-discordant. However, because of the low
numbers of male partners tested, this figure is likely to
be higher. Other studies in Uganda have reported rates
of couples’ HIV sero-discordance at 30% to 50% [23-26].
HIV sero-discordance is a key factor that influences
rates of new infections among couples [36], thus
increasing the risk of mother to child transmission of
HIV during pregnancy, delivery and lactation.
The strength of this trial was the surprisingly compar-
able effect of a letter - a simple, cheap intervention that
was easy to administer - in both arms. It could be
argued that the main limitation of this trial was the high
loss to follow up rate of approximately 40%, reducing
the precision (internal validity) and the power of the
trial to detect differences between the effect of the invi-
tation letter and the information letter.
There are several possible reasons for the high rate of
loss to follow up. Some pregnant women may have con-
tinued receiving antenatal care at lower level health
units (health centres) nearest to their place of residence
on learning from the midwives on their first antenatal
clinic visit that they had low risk pregnancies. Others
may not have attended follow-up ANC visits owing to
transportation problems as the trial site was a referral
hospital. Others could have attended clinics for HIV
counselling and testing services and decided to continue
with ANC elsewhere.
Table 3 Demographic characteristics of study participants
compared between intervention (N = 290) and non-
intervention groups (N = 310)
Characteristics Study groupsP
value
Intervention
n (%)
Non-
intervention
n (%)
Age in yearsa
15-24
25 or more
Place of residence
Rural
Urban
Number of pregnancies
One
Two or more
Education level
No education/incomplete
primary
Completed primary or
more
Marital status
Single/divorced/widowed
Married/cohabiting
Occupation
Salaried
Not salaried
Ethnic group
Bagisu
Non-Bagisu
Religion
Muslim
Christian
Partner’s age in yearsb
19-29
30 or more
Partner’s education level
No education/incomplete
primary
Completed primary or
more
Partner’s occupation
Not salaried
Salaried
153 (52.8)
137 (47.2)
170 (54.8)
140 (45.2)
0.64
197 (67.9)
93 (32.1)
207 (66.8)
103 (33.2)
0.83
64 (22.1)
226 (77.9)
72 (23.2)
238 (76.8)
0.48
120 (41.4)116 (37.40.43
170 (58.6) 194 (62.6)
4 (1.4)
286 (98.6)
6 (1.9)
304 (98.1)
0.75
30 (10.3)
260 (89.7)
44 (14.2)
266 (85.8)
0.19
183 (63.1)
107 (36.9)
192 (61.9)
118 (38.1)
0.83
123 (42.4)
167 (57.6)
126 (40.6)
184 (59.4)
0.72
96 (42.3)
131 (57.7)
103 (45.4)
124 (54.6)
0.51
59 (23.2)56 (21.4)0.45
195 (76.8)206 (78.6)
156 (53.8)
134 (46.2)
168 (54.2)
142 (45.8)
0.99
aThe median age of the pregnant women was 24 years in both the
intervention [interquartile range (IQR): 20-28 years] and non-intervention (IQR:
21-29 years) groups.
bThe male partners’ median age was 30 years in the intervention group (IQR:
26-38 years) and non-intervention group (IQR: 26-35 years), respectively.
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It is possible that community sensitization activities to
encourage men to participate in ANC activities, as car-
ried out in the Khayelitsha trial in South Africa [34],
could have helped reduce the loss to follow up in our
trial. Being a randomized, health facility-based trial, it is
assumed that random allocation of the trial participants
to the comparison groups, and masking of research
assistants, health staff in the antenatal clinic and the
participants, dealt with known and unknown confoun-
ders. As one of the health providers in the hospital, the
principal investigator (RB) did not directly participate in
administering intervention to the trial participants in
order to avoid the Hawthorne effect on the internal
validity of the trial. The findings of this trial could be
generalized country-wide to populations that are similar
to the one in the trial area.
Conclusions
The effect of the intervention and the control on couple
antenatal attendance was similar in both arms of the
trial. In addition, this trial demonstrated that a simple
intervention, such as a letter to the spouse, formulated
as an invitation or as an information letter, could
increase couple attendance by 10%. This intervention
could be implemented in almost all African ANC clinics
with PMTCT at a modest cost.
The trial also demonstrated that the majority (more
than 90%) of the male partners who attended the
antenatal clinic accepted HIV counselling and testing
for HIV. Therefore, there is a requirement to evaluate
this simple, cheap intervention further elsewhere in ade-
quately powered studies to assess its effectiveness in
increasing partner participation in antenatal clinics and
the prevention of mother to child transmission of HIV.
Such studies would better define the trial’s implications
for the PMTCT programme.
Acknowledgements
We would like to thank the antenatal attendees and their male partners
who participated in the trial, and the research assistants who administered
the intervention and collected the data. We would also like to thank the
health staff in the antenatal clinic, who facilitated the tracking of the
participants in the clinic before the exit interviews.
We conducted the trial as part of the Essential Child Health and Nutrition
Project in Uganda, a collaboration between the Department of Paediatrics
and Child Health, School of Medicine, Makerere University College of Health
Sciences and the Centre for International Health, Bergen University. We
received funding for the trial from the Norwegian Council for Higher
Education’s Programme for Development Research and Education (NUFU),
grant no: NUFU PRO-2007/10119.
Author details
1Department of Obstetrics and Gynaecology, Mbale Regional Referral
Hospital, PO Box 921, Mbale, Uganda.2Department of Clinical Dentistry,
Faculty of Medicine and Dentistry, University of Bergen, Postbox 7804, N-
5020 Bergen, Norway.3Department of Paediatrics and Child Health, School
of Medicine, Makerere University College of Health Sciences, PO Box 7072,
Kampala, Uganda.4Clinical Epidemiology unit, School of Medicine, Makerere
University College of Health Sciences, PO Box 7072, Kampala, Uganda.
5Centre for International Health, Faculty of Medicine and Dentistry, University
of Bergen, Postbox 7804, N-5020 Bergen, Norway.
Authors’ contributions
RB participated in the conception, design and implementation of the trial,
statistical analysis, interpretation of data and drafting of the manuscript. ANÅ
participated in interpretation of data and the drafting of the manuscript. GN
participated in the design of the trial, interpretation of data and drafting of
Table 4 Primary and secondary outcomes of the facility based-intervention study at Mbale Regional Referral Hospital,
eastern Uganda
Intervention group:
n/N (%)n/N (%)
Non-intervention group:Unadjusted
ORa(95% CIb)
Adjusted
OR (95% CI)
Primary outcome
Couple antenatal attendance
Intention to treat analysis
Per protocol analysis
Secondary outcome(s)
Partner accepted HIV testd
Partner’s HIV test resultsf
HIV positive
HIV negative
Loss to follow up
Participant’s HIV test results
HIV positive
HIV negative
86/530 (16.2)
86/290 (29.7)
75/530 (14.2)
75/310 (24.2)
1.2 (0.8-1.6)
1.3 (0.9-1.9)1.5 (1.0-2.3)c
82/86 (95.3) 68/75 (90.7)2.1 (0.6-7.5)1.6 (0.4-6.8)e
3/82 (3.7)
79/82 (96.3)
240/530 (45.3)
0 (0)
68/68 (100)
220/530 (41.5) 1.2 (0.9-1.5)
11/290 (3.8)
279/290 (96.2)
14/310 (4.5)
296/310 (95.5)
0.8 (0.4-1.7)
1
aOdds ratio
bConfidence interval
cAdjusted for the participant’s and male partner’s age, occupation and education level, the couple antenatal attendance odds ratio
dPartner acceptance of antenatal HIV testing analyzed per protocol
eAdjusted for male partner’s age, occupation and education level
fFisher Exact test two-sided p value was 0.32
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the manuscript. CASK participated in interpretation of data and the drafting
of the manuscript. TT participated in the conception and design of the trial,
interpretation of data and drafting the manuscript. JKT participated in the
design and implementation of the trial, interpretation of data and drafting
of the manuscript. All authors read and approved the final manuscript.
Competing interests
The authors declare that they have no competing interests.
Received: 13 May 2011 Accepted: 13 September 2011
Published: 13 September 2011
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doi:10.1186/1758-2652-14-43
Cite this article as: Byamugisha et al.: Male partner antenatal attendance
and HIV testing in eastern Uganda: a randomized facility-based
intervention trial. Journal of the International AIDS Society 2011 14:43.
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