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ABSTRACT: OBJECTIVE:: Evaluate the effect of oral and injectable hormonal contraception (HC) on the risk of HIV acquisition among women in South Africa and Zimbabwe. DESIGN:: Secondary data analysis of 4913 sexually active women aged 18-49 years followed for up to 24 months in the MIRA phase III effectiveness trial of the diaphragm and lubricant gel for HIV prevention. METHODS:: Participants were interviewed quarterly about contraception and sexual behavior and were tested for pregnancy, HIV, and other sexually transmitted infections. We used a Cox proportional hazards marginal structural model, weighted by the inverse probability of HC use, to compare the risk of HIV acquisition among non-pregnant women reporting use of combined oral contraceptive pills (COC), progestin-only pills (POP), and/or injectable HC to women not using these methods. RESULTS:: During the study, 283 participants seroconverted. Use of oral contraceptives (POP or COC) was not associated with HIV risk (adjusted hazard ratio (HRa) = 0.86, 95% confidence interval (CI): 0.32, 1.78). Injectable HC was associated with a small non-significant risk of HIV infection (HRa = 1.34, 95% CI: 0.75, 2.37). The effect of injectable HC was similar in the unweighted site-adjusted only (HRa = 1.32, 95% CI: 1.00, 1.74) and baseline factor adjusted models (HRa = 1.27, 95% CI: 0.94, 1.72). CONCLUSIONS:: In this study, oral contraceptives were not associated with HIV acquisition. There is substantial uncertainty in the effect of injectable HC on HIV risk. These findings underscore the importance of dual protection with condoms and the need for diverse contraceptive options for women at risk of HIV infection.
AIDS (London, England) 12/2012; · 4.91 Impact Factor
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ABSTRACT: Duet(®) is a microbicide-delivery system and cervical barrier for use daily or precoitally. We conducted a crossover study among 80 Zimbabwean women to explore factors associated with use-regimen preference. Women were assigned in random order to 14 days of precoital and 14 days of daily Duet and BufferGel use. About 51 % of women preferred precoital use, 39 % preferred daily use, and 10 % liked both equally. Overall product adherence during sex was similar for both use-regimens. In multivariable analysis, diaphragm experience was associated with preference for precoital use (AOR 2.80, 95 % CI 1.01-7.76). Reasons for preferring precoital use included use only when needed, cleanliness, and discomfort with daily use. Daily use preference included convenience, discreetness, and being prepared for "sex-on-demand." Different personal and life circumstances may result in varying use-regimen preferences. Methods that can accommodate both coitally-related and daily use may be advantageous by providing more choice to users.
AIDS and Behavior 07/2012; 16(7):1799-1807. · 3.49 Impact Factor
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JAIDS Journal of Acquired Immune Deficiency Syndromes 08/2011; 57(5):e114-6; author reply e116-7. · 4.43 Impact Factor
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ABSTRACT: There is little data on contraceptive effectiveness or use patterns from sub-Saharan Africa.
We analyzed data from women at risk of pregnancy (n=4905) in the Methods for Improving Reproductive Health in Africa trial of the diaphragm for HIV prevention. We described reported contraceptive method use and calculated rates of pregnancy by contraceptive method. We compared time to first pregnancy by study arm (condoms or condoms plus diaphragm), and estimated a Cox proportional hazards model to identify predictors of pregnancy.
Condoms (25.8%), injectables (25.4%) and OC (21.6%) were the most commonly used methods; long-acting method use was rare. During the trial, 51.6% of women used the same method, 27.4% switched to a more effective method and 20.9% switched to a less effective method; 21.4% of women became pregnant. Pregnancy rates by contraceptive group mirrored published estimates; frequency of study product use was not associated with pregnancy.
Long-acting methods of contraception should be made available in HIV prevention trials and to women in Southern Africa.
Contraception 06/2011; 83(6):556-63. · 2.72 Impact Factor
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Nuriye Nalan Sahin-Hodoglugil, Elizabeth Montgomery,
Deborah Kacanek,
Neetha Morar,
Sibongile Mtetwa,
Busisiwe Nkala,
Jessica Philip,
Gita Ramjee,
Helen Cheng,
Ariane van der Straten,
The Mira Team
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ABSTRACT: Methods for Improving Reproductive Health in Africa (MIRA), a phase III HIV prevention trial, was conducted among 5039 Zimbabwean and South African women to test the Ortho All-Flex diaphragm and Replens(®) lubricant gel. Among the 2418 intervention group participants, 105 women who had completed the trial and 41 male partners participated in focus group discussions and in-depth interviews about the acceptability of the diaphragm and gel and their experiences using the study products. Women who participated in the qualitative study had exited the trial in the prior nine months, were HIV negative, and used the diaphragm and gel for 12-24 months. The comprehensive and flexible conceptual framework was applied to investigate the salient attributes for acceptability of the products as potential HIV prevention methods, and emerging themes for acceptability were framed within three categories of attributes (product, relationship, and sexual intercourse attributes). Both diaphragm and gel were found to be highly acceptable in the study group, and the gel was popular due to its effect of enhancing sexual pleasure. Some of the important product attributes influencing acceptability as reported by users were convenience, ease of use, dual use potential for contraception and disease prevention, and being female-initiated. It was also noted that some elements (such as sexual pleasure, couple communication, and the necessity of diaphragm negotiation) could be more important than others in terms of influencing product acceptability and use. Acceptability attributes reflective of the broader contextual environment (beliefs generated in the trial community suggesting preventive efficacy - preventive method optimism - and gendered norms favoring male superiority in sexual decision making) also emerged as important themes. The high level of acceptability of the diaphragm and gel among MIRA trial participants and their male partners is an indicator of the continued need for an effective female-initiated product.
AIDS Care 04/2011; 23(8):1026-34. · 1.60 Impact Factor
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ABSTRACT: In the context of a multisite HIV prevention trial in Southern African women, we examined the effectiveness of the Ortho All-Flex Diaphragm, lubricant gel (Replens) and condoms compared to condoms alone on the incidence of herpes simplex virus type 2 (HSV-2) infections.
We analysed data from 2016 sexually active women in Zimbabwe and South Africa. Women were followed quarterly, and specimens obtained at the closing visit from previously HSV-2 seronegative women were retested for HSV-2 antibodies using Focus HerpeSelect Elisa. The first visit at which the participant tested positive for HSV-2 was defined by back-testing. We compared the incidence of HSV-2 after randomisation between study arms in both intent-to-treat (ITT) and per-protocol populations.
210 women acquired HSV-2 during study participation (HSV incidence: 6.8 cases/100 women years). Allocation to the intervention arm was found to offer no benefit in reduction of HSV-2 by modified ITT (HR 1.03, 95% CI 0.78 to 1.35; p=0.85) or per protocol analysis (HR 0.87, 95% CI 0.61 to 1.24; p=0.45).
HSV-2 infection was common in the study population as detected by type-specific Elisa testing. Provision of diaphragm and lubricant gel offered no additional protection against HSV-2 acquisition over male condoms alone.
Sexually transmitted infections 03/2011; 87(4):301-5. · 2.18 Impact Factor
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ABSTRACT: The acceptability and use of the diaphragm and lubricant gel were assessed as part of a large randomized controlled trial to determine the effectiveness of the methods in women's HIV acquisition. 2,452 intervention-arm women were enrolled at five Southern African clinics and followed quarterly for 12-24 months. Acceptability and use data were collected by face-to-face interviews at Month 3 and Exit. Participants were "very comfortable" with the physical mechanics of diaphragm use throughout the trial, and approval of the gel consistency, quantity and the applicator was high. At Exit, consistent disclosure of use (AOR 1.97, 95% CI: 1.10-3.55); an overall high diaphragm rating (AOR 1.84, 95% CI: 1.45-2.34) and perception of partner approval (AOR 1.75, 95% CI: 1.35-2.26) were the most significant acceptability factors independently associated with consistent use. Despite being female-initiated, disclosure of use to male partners and his perceived approval of the products were factors significantly associated with their consistent use.
AIDS and Behavior 09/2009; 14(3):629-38. · 3.49 Impact Factor
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ABSTRACT: We examined diaphragm adherence among 2429 women randomized to the intervention arm (diaphragm + gel + condoms) in Methods for Improving Reproductive Health in Africa, a phase III trial of the diaphragm for HIV prevention in Zimbabwe and South Africa.
Women were followed for a median of 7 quarterly visits (range: 1-8 quarterly visits) during which diaphragm adherence was assessed. We conducted trajectory analyses to identify behavioral groups associated with specific diaphragm adherence patterns. Multivariate multinomial logistic regression was used to identify baseline characteristics associated with higher probability of being in a particular trajectory group.
Diaphragm uptake was very high (3.1% never used diaphragms). However, diaphragm adherence was reported at only 49% of visits. Women were clustered into 4 diaphragm adherence groups based on their highest estimated group membership probability: low adherers (31.0%), decreasing adherers (28.9%), increasing adherers (9.3%), and high adherers (30.8%). Women classified as high adherers (as compared with low adherers) were more likely to be older [adjusted odds ratio (AOR) = 1.09, 95% confidence interval (CI): 1.07 to 1.11] and to report baseline condom adherence (AOR = 2.00, 95% CI: 1.47 to 2.71). They were less likely to have high-risk behavior (AOR = 0.51; 95% CI: 0.37 to 0.71) and to have high-risk partners (AOR = 0.58; 95% CI: 0.43 to 0.78). They were most likely to be from the Zimbabwe site (AOR = 2.82; 95% CI: 1.89 to 4.20) and least likely to be from the Johannesburg site (AOR = 0.51; 95% CI: 0.37 to 0.77).
This analytic approach could help to identify high compliers for enrollment in future HIV prevention trials or the types of participants who may need intensive adherence counseling during follow-up.
JAIDS Journal of Acquired Immune Deficiency Syndromes 03/2009; 50(4):419-26. · 4.43 Impact Factor
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ABSTRACT: The MIRA trial assessed whether providing diaphragm, lubricant gel, and condoms (intervention) compared with condoms alone (control) could reduce HIV incidence among 5,039 Southern African women. Compared with the control group, the cumulative proportion of last sex acts protected by any method was higher in the intervention group (OR = 1.33; 95% CI 1.18, 1.49); however, only 36.3% of last sex acts were protected by both a male condom and a diaphragm, whereas 36.6% were protected by a diaphragm only. Product substitution (ever deciding to use a diaphragm instead of a condom in the previous 3 months) was reported at every visit by 22.4%, at some visits by 60.7%, and at none of the visits by 16.8% of these women. Women at greater risk for infection through their own or their partner's behavior or who believed the diaphragm protected against HIV were more likely to report product substitution at every visit.
AIDS and Behavior 01/2009; 13(3):564-72. · 3.49 Impact Factor
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ABSTRACT: We evaluated the effectiveness of the Ortho All-Flex Diaphragm, lubricant gel (Replens) and condoms compared to condoms alone on the incidence of chlamydial and gonococcal infections in an open-label randomized controlled trial among women at risk of HIV/STI infections.
We randomized 5045 sexually-active women at three sites in Southern Africa. Participants who tested positive for curable STIs were treated prior to enrollment as per local guidelines. Women were followed quarterly and tested for Chlamydia trachomatis (CT) or Neisseria gonorrhoeae (GC) infection by nucleic-acid amplification testing (Roche Amplicor) using first-catch urine specimens. STIs detected at follow-up visits were treated. We compared the incidence of first infection after randomization between study arms in both intent-to-treat (ITT) and per-protocol populations.
Baseline demographic, behavioral and clinical characteristics were balanced across study arms. Nearly 80% of participants were under 35 years of age. Median follow-up time was 21 months and the retention rate was over 93%. There were 471 first chlamydia infections, 247 in the intervention arm and 224 in the control arm with an overall incidence of 6.2/100 woman-years (wy) (relative hazard (RH) 1.11, 95% Confidence Interval (CI): 0.93-1.33; p = 0.25) and 192 first gonococcal infections, 95 in the intervention arm and 97 in the control arm with an overall incidence of 2.4/100wy (RH 0.98, 95%CI: 0.74-1.30; p = 0.90). Per protocol results indicated that when diaphragm adherence was defined as "always use" since the last visit, there was a significant reduction in the incidence of GC infection among women randomized to the intervention arm (RH 0.61, 95%CI: 0.41-0.91, P = 0.02).
There was no difference by study arm in the rate of acquisition of CT or GC. However, our per-protocol results suggest that consistent use of the diaphragm may reduce acquisition of GC.
ClinicalTrials.gov NCT00121459.
PLoS ONE 02/2008; 3(10):e3488. · 4.09 Impact Factor
