Peer Health Workers and AIDS Care in Rakai, Uganda:
A Mixed Methods Operations Research
Evaluation of a Cluster-Randomized Trial
Hannah Arem, M.H.S.,1Neema Nakyanjo, M.A.,2Joseph Kagaayi, MBChB, M.P.H.,2
Jeremiah Mulamba, DMHN,2Gertrude Nakigozi, MBChB, M.P.H.,2
David Serwadda, MBChB, M.Sc., MMed,2Thomas C. Quinn, M.D.,3,4Ronald H. Gray, M.D., M.Sc.,1
Robert C. Bollinger, M.D., M.P.H.,3Steven J. Reynolds, M.D., M.P.H.,3,4and Larry W. Chang, M.D., M.P.H.3
Settings with limited health care workers are challenging environments for delivery of antiretroviral therapy.
One strategy to address this human resource crisis is to task shift through training selected patients as peer
health workers (PHWs) to provide care to other individuals receiving antiretroviral therapy. To better under-
stand processes of a cluster-randomized trial on the effect of these PHWs on AIDS care, we conducted a mixed
methods operations research evaluation. Qualitative methods involved patients, PHWs, and clinic staff and
included 38 in-depth interviews, 8 focus group discussions, and 11 direct observations. Quantitative methods
included staff surveys, process, and virologic data analyses. Results showed that task shifting to PHWs posi-
tively affected structural and programmatic functions of care delivery—improving clinical organization, medical
care access, and patient-provider communication—with little evidence for problems with confidentiality and
inadvertent disclosure. Additionally, this evaluation elucidated trial processes including evidence for direct and
indirect control arm contamination and evidence for mitigation of antiretroviral treatment fatigue by PHWs. Our
results support the use of PHWs to complement conventional clinical staff in delivering AIDS care in low-
resource settings and highlight how mixed methods operations research evaluations can provide important
insights into community-based trials.
rural, low-resource settings such as Rakai, Uganda.1,2In 2007,
the World Health Organization (WHO) published a report
on task shifting in AIDS care, emphasizing the need for the
rational distribution of responsibilities among health work
force teams.3Peer health workers (PHWs) are people living
with HIV (PLHIV) and may potentially be a valuable type of
community healthworker(CHW) toassist withtask shifting.4
Recent studies in Uganda and other resource poor areas in
Africa have shown successes for home and community-based
HIV/AIDS services in identifying those with HIV/AIDS and
uman resource limitations pose a significant chal-
lenge to the delivery of antiretroviral therapy (ART) in
improving ART adherence.5,6However, there have been few
rigorous evaluations of the effects and processes of PHWs on
AIDS care outcomes.
From 2006 to 2008, the Rakai Health Sciences Program
(RHSP) and collaborators conducted a cluster-randomized
trial among 15 mobile AIDS clinics to determine whether
PHWs improved ART care outcomes. Details of this inter-
vention and main trial results are reported elsewhere.7In
brief, trained PHWs provided adherence monitoring and
psychosocial support to fellow patients at clinic sites and
during periodic home visits and assisted with triaging sick
patients. The PHW intervention was found to decrease viro-
logic failure rates among patients on ART for 96 weeks or
more. It was also associated with decreased loss to follow-up
1Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
2Rakai Health Sciences Program, Entebbe, Uganda.
3Division of Infectious Diseases, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.
4Laboratory of Immunoregulation, Division of Intramural Research, National Institute for Allergy and Infectious Diseases, National
Institutes of Health, Bethesda, Maryland.
AIDS PATIENT CARE and STDs
Volume 25, Number 12, 2011
ª Mary Ann Liebert, Inc.
but had no effect on adherence measures or on shorter term
This trial was pragmatically oriented, meaning a general
framework for PHW tasks and monitoring was developed,
but the intervention was allowed to adapt to needs and
problems as they arose.8Additionally, this trial occurred in
the setting of a rapidly evolving ART program. Mixed
to understanding complex interventions studies and moving
study findings to programs and policy.9,10We therefore con-
ducted a mixed methods operations research evaluation to
better understand PHW trial results and the underlying pro-
cesses that led to those results.9,11
Study setting and participants
In June 2004, RHSP began providing ART through a Pre-
sident’s Emergency Plan for AIDS Relief (PEPFAR)-funded
mobile clinic program operating in multiple sites throughout
the rural Rakai District in southwestern Uganda. The PHW
trial took place from May 2006 to July 2008. The mixed
methods evaluation took place throughout the trial period
and during a 5-month period following trial completion.
The qualitative portion of this study used in-depth inter-
views, focus groups, and direct observations methods. Study
participants were sampled purposively to ensure a broad
range of perspectives.
ics), we conducted 10 interviews with PHWs (one from each
female, 6 male; age range 32–52). In the control arm (n=5
clinics) we conducted 6 interviews (3 female, 3 male; age
range, 32–42). Ten RHSP clinic staff were also interviewed.
In the intervention arm (n=10 clin-
(two male, two female) in the intervention arm, and two focus
groups (onemale,onefemale) inthecontrolarm.Allthefocus
group participants were drawn from rural-based clinics and
were selected to be representative of the patient population.
These focus groups were composed of 7–10 patients each.
Two mixed gender PHW focus groups were conducted con-
sisting of seven participants each.
We conducted four patient focus groups
sessions were carried out during PHW home visits. Eight di-
rect observations were carried out at mobile clinics in both
intervention and control arms to learn about daily clinic op-
erations of the RHSP ART team and to note relevant differ-
ences between arms.
Three direct observation shadowing
Data collection procedures.
was obtained from all participants. Study investigators and
the qualitative data collection team reviewed and edited
semistructured data collection guides after conducting pilot
interviews. Interview questions were open-ended. Interviews
and focus groups focused on personal experiences with ART
and the PHW program, and how these experiences changed
Written informed consent
over time. In control hubs, the interview and focus group
guides were more generally focused on ART care and support
and information networks, and the experience of living with
HIV. All in-depth interviews and focus groups were tape re-
corded and transcribed. All interviews and focus groups with
patients and PHWs were conducted in Luganda, the pre-
dominant local language. Translation and transcription was
done in a single step by the interviewer or note taker. Inter-
views with clinic staff were conducted in English. Observa-
tion notes were recorded on site and later expanded to a
detailed write-up by the researcher.
NVivo software for coding and analysis (NVivo 8, QSR
International, Victoria, Australia). Transcript review began
while focus groups and interviews were still underway and
participant responses were used to shape questions for future
interviews. After completing line-by-line coding for inter-
views and focus groups, we developed a codebook by cate-
gorizing responses into thematic categories. Quotes from
coded transcripts were triangulated with the original tran-
scripts to ensure appropriate contextualization.
After transcription, data were entered into
Quantitative methods included trial process data analyses,
a Likert scale survey of clinic staff, and patient virologic
outcome data analyses.12
Process data evaluations.
lected throughout the trial, including number and frequency
of PHW home visits to patients, number of patients refusing
home visits, and number of patients assigned to PHWs. Ad-
ditionally, significant programmatic changes were recorded
and summarized to provide contextual information. These
data were all analyzed descriptively.
Process indicators were col-
Likert scale surveys.
strongly, 3=neutral, 5=disagree strongly) was administered
to clinical staff near the end of the trial to assess their views on
the PHW program. These data were analyzed descriptively.
A Likert scale survey (1=agree
Virologic outcomes analyses.
analysis of virologic failure rates of patients at weeks 24 and
48 of ART comparing pretrial to trial time periods. Viral loads
(failure defined as detectable viremia greater than 400 copies
per milliliter) were measured using the Amplicor Monitor
Assay, version1.5(RocheDiagnostics,Branchburg, NJ)witha
lower limit of detection of less than 400 copies per milliliter.
Virologic outcome analyses were by intention to treat using
log-binomial regression with generalized estimating equa-
tions, an exchangeable correlation structure, and robust var-
iance estimates appropriate for cluster-randomized trials.13
Data were analyzed using SAS 9.2 (SAS Institute Inc.,
We conducted post hoc
The trial was approved by Institutional Review Boards at
the Uganda Virus Research Institute’s Safety and Ethics
Committee, the Uganda National Council for Science and
Technology, and Johns Hopkins University.
720 AREM ET AL.
Evidence for direct contamination of control arm
The main trial showed a lack of PHW effect on virologic
outcomes of patients on ART less than 96 weeks or on cu-
mulative risk of virologic failure. Qualitative results sug-
gested that contamination between the trial arms was a
possible explanation for these findings. In the control clinics,
some of the PHWs’ clinic-based tasks were being performed
by untrained and uncompensated patient volunteers. For
example, at one clinic, a patient would register other patients
as they arrived and helped organize triage:
like PHWs. For example, like in Kibaale [control] hub. There is
a gentleman, he really works like a PHW. So when we reach
the patients, which also the PHW do here.So you find, Ki-
baale is also like a [intervention] hub. (Clinic Staff Interview)
Clinic staff expressed how, after seeing subjective logistical
improvements in the intervention arm, staff appointed vol-
serve as a point person to interact with other patients. These
patients’ clinic-based tasks appeared to be mostly adminis-
trative, but they did occasionally give health talks as well.
There was also evidence of modest contamination in home
visit-based tasks. Clinic staff mentioned that self-appointed
individuals in the control arm occasionally offered informa-
tion about missing patients’ whereabouts and status. One
patient in the control arm even began making home visits to
As I told you earlier, health workers had told me that PHWs
have to visit patients in their homes to offer them reassurance
and to see what challenges they have. When they talked about
this issue I also decidedto takeit up. Somepatientsusuallyask
me to forward their challenges/problems to the health work-
ers. I thereby decided to visit patients and identify challenges
which they experience. So by the time we get to the clinic day I
already have something which I can tell to the health workers.
(Male Control Patient Interview)
Evidence for task shifting and indirect contamination
Qualitative findings found that PHWs contributed greatly
to organization in the clinic through task shifting. Clinic staff
noted that before the PHW program, they struggled to orga-
alleviated confusion by registering patients and helping or-
ganize clinic flow. As PHWs began addressing basic patient
care issues, clinic staff reported they had more time to attend
to other patient needs. PHWs would also field questions from
areveryhelpfultoone’s healthbutwemaynot be ableto share
this with health workers. During such sessions the PHW
would be able to advise you about certain issues which the
health workers may not be able to help about because you
freely because he is a friend. Indeed you may not be so free to
share all this with a health worker who comes in once in a
while. (Male Patient Focus Group)
In the community, PHWs’ home visits provided an op-
portunity to assess personal factors such as alcohol use that
might affect adherence and not be as apparent in a clinic
setting. Additionally, PHWs were able to address various
concerns about ART that promoted patient adherence and
saved patient time and money traveling to health facilities for
support. For example, PHWs were able to counsel patients on
correct medication taking and adherence strategies:
Septrin. She could instead take two tablets of Septrin thinking
it is Nevirapine.So I talked to her mother.and I told her to
separate the drugs for her..I told her to give her every
morningand in the evening. She is now fine and was even able
to help other patients on how to go about with the drugs.
(Female PHW Focus Group)
Before the PHW program began, several clinic staff noted
they would spend significant time and resources (e.g., fuel for
transport) personally going out in to the field to address
similar types of issues. PHWs were perceived to reduce the
overall workload for clinic staff and allowed them to provide
better overall patient care. While these task shifting effects
were most noticeable in the intervention arm, there did ap-
pear to be indirect contamination of the control arm through a
generalized improvement in program-wide efficiency.
Virologic evidence for global
Table 1 compares 24 and 48 week virologic failure rates
before and during the trial period. Notably, the 24 and 48
week failure rates were significantly decreased during the
trial period in both arms compared to before. Contextual
process data showed that a number of other programmatic
improvements were implemented during the study period
besides the PHW intervention. These improvements included
the use of viral load results to guide care, more focused ART-
related messaging, enhanced adherence counseling, chart
stickers to help identify treatment failures, and second-line
ART provider talks. Qualitative results also suggested that
Table 1. Virologic Failure Rates Within Study Arm Before and During Study Period
Weeks from ART initiation ArmBefore study % failing (n/N)During study % failing (n/N)RR (95% CI)p Value
ART, antiretroviral therapy; PHW, peer health worker; RR, risk ratio; CI, confidence interval.
PEER HEALTH WORKERS AND AIDS CARE 721
of the study period in better delivering ART. These global
programmatic improvements resulted in lower than initially
anticipated rates of virologic failures.
Impact on long-term ART patients
The trial showed that the PHW intervention decreased vi-
rologic failure rates among long-term patients on ART for 96
weeks or more.7The early ART-related difficulties cited by
patients included stigma, side effects, and technical under-
standing of how to take the therapy. Months or years after
ART initiation, different adherence challenges emerged, in-
cluding a sense that they were ‘‘cured,’’ ‘‘treatment fatigue,’’14
or difficulty maintaining their drug schedule at work. PHWs
appeared to positively impact many of these later adherence
If he [PHW] takes a month without visiting, you certainly be-
drugs feeling that you are fully cured. In fact there are so many
patients who withdraw from using drugs because they now
feel they have cured up completely. In fact a PHW has a very
big role to play during such a situation. He comes in to en-
courage you to take your drugs. They are doing an important
job. (Male Patient Interview)
Impact on loss to follow-up
In the trial, fewer patients were lost to follow-up in the
PHW intervention arm than in the control arm. Some PHWs
noted patient mobility which created difficulties in following
through with treatment7:
You just see a person asking for drugs, when you ask her, she
says I came from this community, people tell you that she is
staying somewhere at her place. When you reach her place,
they tell you that she shifted and went back to the other side.
(Peer Health Worker Interview)
Qualitativeanalyses showed that PHWswereable tolocate
missing patients due to their presence in the community,
which facilitated patient tracing and retention in care.
Impact on confidentiality and stigma
Qualitative findings supported the concept that PHWs had
a direct role in many patients’ lives, providing psychosocial
support and combating stigma. As one patient noted:
People in the community can stigmatize to an extent that you
even fear to leave the house and are very worried. You can tell
the PHW that I fear to leave the house because people stig-
matize me.and the PHW tells you that you should be firm,
people will talk and get tired, if you keep taking your drugs
your health will improve and people will no longer have
anything to say about you. (Female Patient Focus Group)
Many patients also felt that PHWs were able to help pro-
tect confidentially rather than putting them at risk for un-
Before the PHW came in we had a problem because you had to
to someone who could provide you with assistance. By so
doing everyone got to know your problem, even those who
cannot assist you and those who would go around gossiping
aboutyourproblemto otherpeople.Sothis wasabig problem.
the PHWs. (Male Patient Focus Group)
Impact on adherence
Clinic staff responses to the Likert scale survey (Table 2)
and qualitative interviews showed that staff believed PHWs
were positively impacting adherence.
to the patients themselves. In most cases the PHWs have come
out to tell us the truth behind every patient we interact with.
PHWs have always come to our rescue. (Clinic Staff Interview)
Patients themselves also noted improved engagement in
care in their community. As patients saw relatives, friends,
and other peers recovering from illness, patients developed
hope that their own health would also improve and thus re-
dedicated efforts to attend clinic sessions and adhere to ART.
In the past, the PHW could go to a patient’s home and they
could not know that he or she is a PHW but now they see the
PHW going to a very ill person and after a short period of time
they see a person walking normally. This prompts them to join
us after seeing the importance of it. (Female Patient Focus
Areas for improvement
A number of areas for improvement of the PHW program
were identified. Clinic staff suggested increasing the numbers
of PHWs, more frequent retraining on drug regimen adjust-
ments, and a more generous stipend system (referred to
Table 2. Clinic Staff Responses to PHW
The PHW program improved the
overall care of the clinic patients.
Patients who talked to a PHW
before initiating ART had
a better understanding of the
importance of adhering to ART.
Review of PHW home visit forms
was helpful in identifying patients
with special adherence
Review of PHW home visit forms
was helpful in identifying patients
with special clinical concerns
(e.g., side effects, new illnesses, etc.).
The PHW program made
my job easier.
The PHW program should
be scaled up to all the hubs.
The PHW program should
38 1.54 (0.55) [1–3]
37 1.59 (0.63) [1–3]
37 1.54 (0.59) [1–3]
36 1.72 (0.72) [1–3]
39 1.72 (0.71) [1–3]
39 1.15 (0.48) [1–3]
39 4.75 (0.37) [4–5]
a1=agree strongly; 2=agree, 3=neutral, 4=disagree, 5=disagree
PHW, peer health worker; SD, standard deviation; ART, anti-
722AREM ET AL.
locally as ‘‘facilitation’’). Many PHWs also commented on the
need for increased stipends, noting how PHW home visiting
took time away from other gainful work. Clinic staff and
PHWs both suggested refresher trainings and more frequent
discussions on the ideal interactions between staff and PHWs.
Concerns with intervention intensity were also noted.
visits, but by study end there were about 25–30 patients per
PHW, significantly higher than the initial 15:1 goal. As one
staff member noted:
Some [PHWs] have many more patients to see and we
don’t know whether it will reduce the effectiveness of the
program..And well, we are looking at patients coming from
different directions all over, although we have a PHW in each
geographic region, but sometimes we want to take care of a
patient who is on the other side of the geographical region and
that means the PHW has to travel long distances to get to see
the patient. (Clinic Staff Interview)
Process indicators showed that PHWs eventually averaged
monthly rather than biweekly contacts. Inclement weather,
absent patients, and transportation challenges were cited as
common obstacles to more frequent visitation.
Clinic staff survey results
Likert Scale survey results (Table 2) largely echoed results
from the qualitative evaluation. Clinic staff generally had
positive impressions of the PHW program and felt it im-
proved adherence, clinical management, retention in care,
and eased their own work. They felt the PHW program
should be scaled up and continued after the study period.
A mixed methods operations research evaluation of a
cluster-randomized trial on the impact of PHWs on AIDS care
revealed several themes from qualitative analyses which
helped improve understanding of trial findings and under-
lying processes. Quantitative analyses from this evaluation
largely complimented these qualitative results. HIV/AIDS
programs and future operations/implementation research
endeavors in similar settings may benefit from these study
methods and insights.
A key discovery of this evaluation was evidence for both
direct and indirect contamination of the control arm. Direct
contamination occurred when some patients began volun-
tarily taking up PHW tasks in the control arms. Indirect
contamination occurred through task shifting which resulted
have reduced the ability of the study to detect intervention
effects, and may help explain why no differences were seen in
early virologic outcomes between arms or in cumulative risk
of virologic failure.
In comparisons of before and during trial 24 and 48 week
virologic failure rates within arms, both study arms demon-
strated dramatic improvement during the trial. These results
could have been due to a secular trend, but could also be
evidence for the PHW program positively impacting both the
intervention arm as well as control arm through task shifting.
From a study rigor perspective, possible contamination was
not desirable in that between arm differences may have been
attenuated, but programmatically it may have been beneficial
in improving overall viral suppression. This finding demon-
strates the tensions which will be inherent in many opera-
tional and implementation studies which must balance study
design with pragmatic, programmatic considerations.10,15,16
in dealing with these challenges appeared to differ between
patients on ART for short compared to longer amounts of
time. These different adherence barriers may help explain
why PHWs were found to have a significant effect on patients
on longer term ART. ‘‘Treatment fatigue’’ is an increasingly
important public health issue, and PHWs may be an effective
intervention to sustain ART.2Future studies may also seek to
further explore the relationship between adherence percep-
tion, adherence reporting, and virologic outcomes.
The processes by which PHWs contributed to decreasing
lost to follow-up rates appeared straightforward. PHWs were
present in and knowledgeable about the community and
could ably assist with tracking down patients. Retention in
care is critical to successful ART programs and the role of
PHWs in addressing this issue may be significant.17,18Ad-
ditionally, PHWs were noted to be consistent and reputable
thecommunities. PHWsdidnot haveanyobvious deleterious
effects on disclosure and confidentially. Some of these po-
tential benefits of peers have been noted before, although
Process indicators showed that while PHWs generally
fulfilled their tasks, they did not visit patients as frequently as
initially planned, and intervention efficacy may have been
blunted. The optimal work load and patient ratios for PHWs
remains unclear. However clinic staff and PHWs largely en-
dorsed the end of study PHW to patient ratios as being
manageable. Another challenge was determining appropriate
PHW stipends. Recent WHO guidance suggests compensa-
tion should outweigh opportunity costs for health workers to
encourage retention.1No PHWs quit during this study, sug-
gesting their compensation was sufficient.
Study limitations included limited generalisability of some
study findings as the evaluation and intervention were im-
plemented in the setting of a relatively atypical, mobile clinic
approach within a program with longstanding research ex-
perience.21Since this trial was carried out within an evolving
ART delivery program, it was difficult to have a control arm
that could isolate the secular trends while remaining repre-
sentative of the patient population. Optimizing controls for
operational research trials is a challenging issue for the field,
and they should be carefully and pragmatically selected in
future trials. Although researchers attempted to use a variety
of data collection methods to reduce response bias and in-
formed consent emphasized participant protections, study
participants may have withheld criticism out of respect for
the program or fear of retribution. Also, translation and
transcription wasdoneinasinglestep, which couldintroduce
bias, and field notes were written up after observations and
could be subject to recall bias. Finally, parts of this evaluation
were carried out over a short period of time and may not have
fully captured the changes that were occurring over the entire
length of the trial.
This mixed methods operations research study supports
strategies to task shift medical care and may have relevance
to other ART programs and operations/implementation
PEER HEALTH WORKERS AND AIDS CARE 723
research. Future research should further detail the capabilities Download full-text
of PHWs to improve clinical productivity in delivery of HIV/
AIDS care, and how to best optimize their effectiveness.
Mixed methodology should be pursued when assessing ran-
domized trial outcomes to understand trial results and pro-
cesses, and to best ensure the effective translation of study
findings into policy and programs.
We thank the patients and staff of the Rakai Health Sciences
Program for their dedication, support, and compassion. This
study was funded by the Doris Duke Charitable Foundation,
The DivisionofIntramural Research,The NationalInstitute for
Allergy and Infectious Diseases, National Institutes of Health,
andNational InstitutesofHealth Training(2T32-AI07291) and
Career Development (1K23MH086338-01A2) grants.
Author Disclosure Statement
No competing financial interests exist.
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Address correspondence to:
Larry William Chang, M.D., M.P.H.
Division of Infectious Diseases
Department of Medicine
Johns Hopkins School of Medicine
1503 East Jefferson Street, Room 116
Baltimore, MD 21287
724 AREM ET AL.