Reproductive Health In Africa Research Articles

Changing direction for health in Africa.

Current developments augurs well for sexual and reproductive health in Africa. With the African Union joining the G20 group, it is expected that its regional health priorities will be given special consideration. Social protection and empowerment of youth and women were prominent at the recent Summit of the Future. The impending change in leadership at the African regional office of the World Health Organization brings great expectations for sound policy formulation and surveillance for detecting outbreaks of epidemics. At the United Nations, Africa will benefit from reform of the Security Council besides intensified activities pertaining to the Sustainable Development Goals.

Incidence of sexually transmitted infections during pregnancy.

Prevalence of sexually transmitted infections (STI) is high among pregnant women in certain settings. We estimated STI incidence and compared STI risk in pregnant and non-pregnant women. Data came from the Methods for Improving Reproductive Health in Africa (MIRA) study conducted in South Africa and Zimbabwe 2003–2006. Women aged 18–50 years with at least one follow-up visit within 6 months of enrollment were included. Follow-up visits included laboratory testing for pregnancy, chlamydia, gonorrhea, trichomoniasis, and HIV, as well as self-report of hormonal contraceptive (HC) use, sexual behaviors and intravaginal practices. All visits were classified according to pregnancy status. Incidence of each STI was calculated using follow-up time. Cox proportional hazards models were fitted using pregnancy as a time-varying exposure and sexual behaviors and intravaginal practices as time-varying covariates. Among 4,549 women, 766 (16.8%) had a positive pregnancy test. Median follow-up time was 18 months [IQR: 12–24]. The overall incidence rate of chlamydia was 6.7 per 100 person years (py) and 9.9/100py during pregnancy; gonorrhea incidence was 2.7/100py and 4.9/100py during pregnancy; trichomoniasis incidence was 7.1/100py overall and 9.2/100py during pregnancy. Overall HIV incidence was 3.9/100py and 3.8/100py during pregnancy. In crude models, pregnancy increased risk for chlamydia (hazard ratio (HR) 1.5, 95%CI: 1.1–1.2), however there was no increased risk of any measured STI in adjusted models. STI Incidence was high during pregnancy however pregnancy did not increase STI risk after adjustment for sexual behaviors. Greater efforts are needed to help pregnant women avoid STIs.

Socio-demographic and behavioural characteristics associated with HSV-2 sero-prevalence in high risk women in KwaZulu-Natal.

BackgroundThe World Health Organization estimates that 536 million people aged 15–49 are infected with Herpes simplex virus type 2 (HSV-2), the causative agent of genital herpes. The aim of this study was to investigate the role of behavioral and demographic factors that contribute to the high HSV-2 sero-prevalence among women participating in a HIV prevention trial. The Methods for Improving Reproductive Health in Africa (MIRA) study assessed the effectiveness the latex diaphragm and lubricant gel on HIV prevention among women in South Africa and Zimbabwe. At screening an interviewer administered questionnaire on demographics and sexual behaviour was obtained. HSV-2 serum antibodies were detected using HerpeSelect™ ELISA IgG. Statistical analysis was performed using STATA release 12.0. This study was registered with ClinicalTrials.gov,number NCT00121459 on the 28th February 2007.FindingsOf the 3 472 women screened at the Durban research sites 2 218 (73%) had a prevalent HSV-2 infection and 1431 (41%) of the women were also co-infected with HIV. In the multivariate analyses, older women (adjusted odds ratio) [aOR]: 3.49, 95% CI: (2.71,4.49) for >35 years and aOR: 1.82, 95% CI: 1.49, 2.22 for 25–34 years compared with <25 years, p < 0.001 for both comparisons were more likely to be HSV-2 sero-positive. Low level of education (OR: 1.26 95% CI: 1.03, 1.53), having >1 life-time sexual partners (OR: 2.48, 95% CI: 1.92, 3.20), parity >1 (OR: 1.95 95% CI: 1.92, 3.20) and being HIV positive (OR: 6.31, 95% CI: 5.06, 7.88) were significantly associated with HSV-2 infection.ConclusionThe high sero-prevalence of HSV-2 in the studied population is of great public health importance since this high risk population could act as a reservoir for future infections particularly HIV transmission.

Human rights advances in women’s reproductive health in Africa

The African Commission on Human and Peoples’ Rights recently adopted General Comment No 2 to interpret provisions of Article 14 of the Protocol to the African Charter on the Rights Women. The provisions relate to women’s rights to fertility control, contraception, family planning, information and education, and abortion. The present article highlights the General Comment’s potential to promote women’s sexual and reproductive rights in multiple ways. The General Comment’s human rights value goes beyond providing states with guidance for framing their domestic laws, practices, and policies to comply with treaty obligations. General Comment No 2 is invaluable in educating all stakeholders—including healthcare providers, lawyers, policymakers, and judicial officers at the domestic level—about pertinent jurisprudence. Civil society and human rights advocates can use the General Comment to render the state accountable for failure to implement its treaty obligations.

A Qualitative Exploration of South African Women’s Psychological and Emotional Experiences of Infertility

Despite the high prevalence of infertility in Africa, the study of reproductive health in Africa, has for the most part, not addressed the impact of involuntary childlessness on women. In contrast, the health priority has been on fertility regulation rather than on infertility. In Sub-Saharan Africa, at least 20% - 50% of couples of reproductive age experience a fertility problem and 30% are diagnosed with infertility. This study explored a sample of South Africa women’s psychological and emotional experiences of infertility or involuntary childlessness. Utilising a qualitative methodology, 21 married women who were diagnosed with infertility were recruited. Semi-structured, indepth individual interviews were conducted and the data were analysed using thematic analysis. The results of the study indicated that the women reported emotional turmoil characterised by emotions such as disappointment and shock, anger and frustration, a deep sense of sadness and then progressed to experience a sense of acknowledgement that a problem existed. Within each of these emotional phases the emotions of hope and optimism were present. The findings of this study suggest that severe psychological and emotional tug-of-war effects accompany infertility. Possible coping strategies for women struggling with infertility are discussed.

Oral and injectable contraception use and risk of HIV acquisition among women in sub-Saharan Africa

To evaluate the effect of oral and injectable hormonal contraception on the risk of HIV acquisition among women in South Africa and Zimbabwe. Secondary data analysis of 4913 sexually active women aged 18-49 years followed for up to 24 months in the Methods for Improving Reproductive Health in Africa (MIRA) phase III effectiveness trial of the diaphragm and lubricant gel for HIV prevention. 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 hormonal contraception use, to compare the risk of HIV acquisition among nonpregnant women reporting use of combined oral contraceptive pills (COC), progestin-only pills (POP), and/or injectable hormonal contraception to women not using these methods. 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 hormonal contraception was associated with a small nonsignificant risk of HIV infection (HR(a) = 1.34, 95% CI 0.75, 2.37). The effect of injectable hormonal contraception was similar in the unweighted site-adjusted only (HR(a) = 1.32, 95% CI 1.00, 1.74) and baseline factor adjusted models (HR(a) = 1.27, 95% CI 0.94, 1.72). In this study, oral contraceptives were not associated with HIV acquisition. There is substantial uncertainty in the effect of injectable hormonal contraception 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.

Dyeing to Know

Dyeing to Know

Measuring gender and reproductive health in Africa using demographic and health surveys: the need for mixed-methods research

Understanding gender in Africa is essential to creating policy and designing interventions to address key reproductive-health issues such as HIV/AIDS and maternal mortality that are particularly pressing for the continent and are strongly related to gender inequality. The addition of questions to capture women's empowerment and autonomy on the MEASURE/Demographic and Health Surveys (DHS) in the late-1990s expanded opportunities to examine the relationship between gender and reproductive health. These questions provide valuable information on trends and individual-level associations between gender inequality and health. Given that women's empowerment, status and autonomy are largely dependent on contextually-specific gender systems, however, supplementary qualitative studies to validate and contextualise these data would strengthen analyses significantly. This paper provides examples of how such mixed-methods work would improve understandings of gender and reproductive health in Africa by validating survey questions, providing insights into how to analyse and interpret DHS data and illuminating the processes and mechanisms behind gendered experiences. Additionally, this work could help improve future survey research on gender and reproductive health.

Changes in Sexual Risk Behavior Before and After HIV Seroconversion in Southern African Women Enrolled in a HIV Prevention Trial

We examine changes in sexual risk behaviors before and after HIV seroconversion in southern African women enrolled in the Methods for Improving Reproductive Health in Africa trial. HIV testing and counseling, and assessment of sexual behaviors by audio computer-assisted self-interviewing were performed approximately every 3 months. We compared the following sexual behaviors: being sexually active, coital frequency, consistent male condom use, use of any female condoms, anal sex, and >1 sex partner, at study visits before and after HIV seroconversion. During the trial, 327 women seroconverted to HIV, contributing 718 pre-HIV and 1110 post-HIV study visits. Women were significantly more likely to report consistent condom use at visits after HIV seroconversion compared with visits before HIV infection [adjusted odds ratio, (AOR): 1.36 (95% confidence interval (CI): 1.11 to 1.67)] and were less likely to have >1 male sex partner after serconversion [AOR: 0.66 (95% CI: 0.48 to 0.91)]. Women reported less frequently being sexually active [AOR: 0.63 (95% CI: 0.39 to 1.02)], fewer episodes of sex [>4 sex acts over the past week AOR: 0.74 (95% CI: 0.60 to 0.91)], and a reduction in anal sex [AOR: 0.58 (95% CI: 0.36 to 0.95)] at visits after HIV seroconversion. The observed reductions in sexual risk behaviors persisted over time. Women significantly decreased their sexual risk behaviors after HIV seroconversion, but these changes were relatively modest, suggesting the need for further secondary prevention. Timely notification of HIV status coupled with prevention messages can contribute to reductions in sexual risk behaviors.

African Women Recently Infected With HIV-1 and HSV-2 Have Increased Risk of Acquiring Neisseria gonorrhoeae and Chlamydia trachomatis in the Methods for Improving Reproductive Health in Africa Trial

Neisseria gonorrhoeae and Chlamydia trachomatis are 2 common causative agents of cervical bacterial sexually transmitted infections (STI). Against the background of the concurrent epidemics of STIs and HIV in sub-Saharan Africa, we examined the effect of HIV-1 and HSV-2 on acquiring N. gonorrhoeae and C. trachomatis in a cohort of southern African women at risk for HIV infection. We examined incidence of first infection with N. gonorrhoeae and C. trachomatis in the multisite randomized controlled trial Methods for Improving Reproductive Health in Africa. Multivariable Cox proportional hazards models with time-dependent covariates were used. The incidence rates of C. trachomatis and N. gonorrhoeae infections were 6.14 per 100 woman-years and 2.42 per 100 women-years, respectively. In multivariable analyses, women who became infected with HIV-1 were more likely to acquire C. trachomatis (adjusted hazard ratio [adj. HR], 1.86; 95% confidence interval [CI], 1.34-2.57) and N. gonorrhoeae (adj. HR, 2.29; 95% CI, 1.47-3.56) compared with HIV-uninfected women. Similarly, HSV-2 infected women were more likely to acquire C. trachomatis (adj. HR, 1.29; 95% CI, 1.05-1.58) and N. gonorrhoeae (adj. HR, 1.57; 95% CI, 1.11-2.21). Women who were of younger age, who did not live with their primary male partner, and who changed sex partners during the study were also more likely to acquire a cervical STI. Women recently infected with HIV-1 and HSV-2 were at increased risk of acquiring N. gonorrhoeae and C. trachomatis. Proactive screening and treatment of these common cervical infections, particularly among those infected with HIV-1 and HSV-2, should be considered for young sexually active women in settings with a high prevalence of HIV/STIs.

On Male Role and Responsibility for Reproductive Health in Africa

The literature on male role and responsibility for reproductive health in Africa supports the impression that African men are uninterested in the consequences of their reproductive behaviour. This paper argues this view to be inaccurate and historical. The perceived apathy results from the feminization of reproductive knowledge and its confinement to clinical settings, which exclude and alienate men. Men were indeed principal providers of healthcare for their households in the pre-colonial period but were dislodged from this role by the incorporation of their societies into the international labour market, thereby creating working class poverty, and weakening their role in this regard in Nigerian family life. The campaign to involve men in reproductive health programmes should be accompanied by poverty alleviation and family support schemes to mitigate rising costs of modern medical care for themselves, their partners, and their children.

User experiences and acceptability attributes of the diaphragm and lubricant gel in an HIV prevention trial in southern Africa

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.

The relative contribution of viral and bacterial sexually transmitted infections on HIV acquisition in southern African women in the Methods for Improving Reproductive Health in Africa study

We assess the relative contribution of viral and bacterial sexually transmitted infections (STIs) on HIV acquisition among southern African women in a nested case-control study within the Methods for Improving Reproductive Health in Africa (MIRA) trial. Cases were women with incident HIV infection; controls were HIV-uninfected at the time of case seroconversion selected in a 1 to 3 case to control ratio (risk-set sampling), matched on study site and time of follow-up. Conditional logistic regression models were used to calculate adjusted odds ratios (AORs) and population-attributable fractions (PAF). Among 4948 enrolled women, we analysed 309 cases and 927 controls. The overall HIV incidence rate was 4.0 per 100 women-years. The incidence of HIV infection was markedly higher in women who had prevalent Herpes simplex virus type 2 (HSV-2) (AOR: 2.14; 95% confidence interval [CI]: 1.55-2.96), incident HSV-2 (AOR: 4.43; 95% CI: 1.77-11.05) and incident Neisseria gonorrhoeae (AOR: 6.92; 95% CI: 3.01-15.90). The adjusted PAF of HIV incidence for prevalent HSV-2 was 29.0% (95% CI: 16.8-39.3), for incident HSV-2 2.1% (95% CI: 0.6-3.6) and for incident N. gonorrhoeae 4.1% (95% CI: 2.5-5.8). Women's greatest risk factors for HIV acquisition were incident bacterial and viral STIs. Women-centred interventions aimed at decreasing HIV incidence in young African women need to address these common co-morbid conditions.

Establishing a continuum of care between HIV prevention trials and public healthcare systems: The MIRA Standard of Care program

The ability of researchers to provide sustainable care to individuals who acquire HIV during participation in HIV prevention trials has rapidly expanded along with national treatment options. The for Improving Reproductive Health in Africa (MIRA) trial (2003-2006), a phase III multi-site randomized controlled trial, measured the effectiveness of the diaphragm used with Replens lubricant gel in preventing heterosexual acquisition of HIV among women in Zimbabwe and South Africa. The MIRA Standard of Care program, which started towards the end of the trial period and continued for 5 months after trial closeout, enabled women who acquired HIV during the trial to receive additional counseling and clinical care and facilitated links to long-term HIV-related care and treatment from public health facilities. To describe eligible participants' uptake of these optional services and evaluate the program's strengths and limitations. Methods All women who acquired HIV during their MIRA participation were re-contacted and invited to return to the study clinics for additional care and referrals. Sites reported monthly statistics of uptake of services. From start to end, 185 of 323 (57%) HIV-positive participants accepted additional care; 81 (25%) could not be relocated. 142 (44%) women received referrals to government healthcare facilities and 90 (28%) enrolled in wellness/ treatment programs. Fifty-seven (18%) declined further care, but reasons for doing so were not recorded systematically. The program began after most participants had exited from the MIRA trial and required re-contacting women, resulting in difficulty in locating some participants. In the future, care for participants who seroconvert should be offered at the trial onset and fully integrated into clinical trials to avoid losing these participants for further care. More research is needed to identify and understand perceived barriers to establishing a continuum of care between clinical trials and public sector health facilities. Clinical Trials 2010; 7: 256-264. http:// ctj.sagepub.com.

Adding to the menu of modern methods - the diaphragm

As a prying adolescent I one day opened my mother’s hidden, shell-like, plastic case and found her carefully washed and powdered diaphragm, smelling slightly of rubber. I marvelled that she could be sufficiently well organised to safely store and use this device to prevent babies. I now better understand her strength of motivation – and the value there must have been for her of being in control of contraception, given my father’s Catholic faith. For decades the diaphragm was used successfully as a method of contraception by millions of women in developed countries. With the advent of the highly convenient Pill in the 1960s its popularity waned – and the diaphragm never became well established as an option in developing countries. In this issue, Coffey and Kilbourne-Brook contend that the use of the diaphragm in low-income settings should be reconsidered. 1 They present findings from their acceptability study about the ways that women in the Dominican Republic, South Africa and Thailand were able to use, clean and store a diaphragm. Their findings support the idea that motivated women in low-income settings would find ways to use and care for the device appropriately. In recent years the diaphragm has received renewed attention because of hope that it might enable women to protect themselves against sexually transmissible infections (STIs) and HIV. 2 It is plausible that the diaphragm could be protective because it covers the cervix, which is more susceptible to infection with HIV, chlamydia and gonorrhoea than the vaginal mucosa. Early observational studies suggested that the diaphragm prevents STIs, 3,4 although diaphragm users may have been at lower risk for other reasons. A randomised controlled efficacy study, the ‘Methods for Improving Reproductive Health in Africa’ (MIRA) trial of the diaphragm and Replens ® lubricant gel (Lil’ Drug Store Products

Change in condom and other barrier method use during and after an HIV prevention trial in Zimbabwe

BackgroundWe examined the use of male condoms and the diaphragm following completion of a clinical trial of the diaphragm's HIV prevention effectiveness. In the trial, called Methods for Improving Reproductive Health in Africa (MIRA), women were randomized to a diaphragm group (diaphragm, gel and condoms) or a condom-only control group. At trial exit, all women were offered the diaphragm and condoms.MethodsOur sample consisted of 801 Zimbabwean MIRA participants who completed one post-trial visit (median lapse: nine months; range two to 20 months). We assessed condom, diaphragm and any barrier method use at last sex act at enrolment, final MIRA and post-trial visits. We used multivariable random effects logistic regression to examine changes in method use between these three time points.Results and discussionIn the condom group, condom use decreased from 86% at the final trial visit to 67% post trial (AOR = 0.20; 95% CI: 0.12 to 0.33). In the diaphragm group, condom use was 61% at the final trial visit, and did not decrease significantly post trial (AOR = 0.77; 95% CI: 0.55 to 1.09), while diaphragm use decreased from 79% to 50% post trial (AOR = 0.18; 95% CI: 0.12 to 0.28). Condom use significantly decreased between the enrolment and post-trial visits in both groups. Use of any barrier method was similar in both groups: it significantly decreased between the final trial and the post-trial visits, but did not change between enrolment and the post-trial visits.ConclusionsHigh condom use levels achieved during the trial were not sustained post trial in the condom group. Post-trial diaphragm use remained relatively high in the diaphragm group (given its unknown effectiveness), but was very low in the condom group. Introducing "new" methods for HIV prevention may require time and user skills before they get adopted. Our findings underscore the potential benefit of providing a mix of methods to women as it may encourage more protected acts.

Degrees of disclosure: A study of women's covert use of the diaphragm in an HIV prevention trial in sub-Saharan Africa

In sub-Saharan Africa more women are infected with HIV/AIDS than men and new prevention methods are urgently needed. One major attribute of female-initiated HIV prevention methods is that they can be used covertly, without a male partner's knowledge. Using mixed methods, we explored the predictors and dimensions of covert use of the diaphragm in a randomized controlled trial that tested its effectiveness for HIV prevention. The Methods for Improving Reproductive Health in Africa (MIRA) trial was conducted in Zimbabwe and South Africa, and data collection took place between September 2003 and January 2007. This study is a secondary analysis of quantitative and qualitative data from participants randomized to the intervention group, and their male partners. It includes survey data from 2316 women (mean age=28.3), 14 focus group discussions (FGD) conducted with 104 women, and 7 FGD and 10 in-depth interviews with 37 male partners. The median follow-up for trial participation was 21 months (range: 12-24). At their final visit, approximately 9% of women had never disclosed to their primary partners that they were using the diaphragm (covert use). In multivariate analysis, predictors of covert use included being older, not co-habiting with the partner, having a partner who did not use condoms, and being from South Africa. Qualitative analysis revealed that covert use was not dichotomous, but ranged along a continuum, which we categorized into five levels (i.e. full disclosure; mostly open use; occasional covert use; mostly covert use; and completely covert use). We discuss the critical role of the option of covert use for many women in the context of an HIV prevention trial, as well as gender power dynamics which may influence women's decisions about disclosure.

Novel strategies implemented to ensure high participant retention rates in a community based HIV prevention effectiveness trial in South Africa and Zimbabwe

Background The identification of new HIV prevention methods that women can initiate themselves are urgently needed, particularly in high prevalence settings. HIV prevention trials must be designed with large sample sizes and/or substantial follow-up periods to ensure enough statistical power to measure product effectiveness. This paper describes the attendance rates of the Methods for Improving Reproductive Health in Africa (MIRA) trial, reasons for missed visits, and strategies used to retain participants; and examines demographic and behavioural predictors of retaining women. Methods HIV negative, sexually active females were enrolled into the MIRA trial in Zimbabwe and South Africa. Once enrolled, women were expected to visit the clinic at 2 weeks and quarterly thereafter for 12 to 24 months. Tabulations of visit-specific retention rates are presented, along with a descriptive summary of retention strategies established prior to and in response to challenges incurred during implementation. Both univariate and multivariate logistic regression models were created in STATA to examine predictors of being retained vs. lost-to-follow-up. Results At the three sites, the final retention rates were 94%, 93% and 89% for Zimbabwe, Durban and Johannesburg, respectively. This was achievable through intensive outreach efforts toward the latter part of the trial and a commitment from all staff. Each site implemented several retention strategies. Conclusion The high retention rates were achievable in this trial through added staff efforts and resources. Community involvement was also crucial to achieve these rates. Retention of trial participants should be considered during trial design and implemented from the onset.

Patterns and Predictors of Adherence to Diaphragm Use in a Phase III Trial in Sub-Saharan Africa: A Trajectory Analysis

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.

Analyzing Direct Effects in Randomized Trials with Secondary Interventions: An Application to HIV Prevention Trials.

The Methods for Improving Reproductive Health in Africa (MIRA) trial is a recently completed randomized trial that investigated the effect of diaphragm and lubricant gel use in reducing HIV infection among susceptible women. 5,045 women were randomly assigned to either the active treatment arm or not. Additionally, all subjects in both arms received intensive condom counselling and provision, the "gold standard" HIV prevention barrier method. There was much lower reported condom use in the intervention arm than in the control arm, making it difficult to answer important public health questions based solely on the intention-to-treat analysis. We adapt an analysis technique from causal inference to estimate the "direct effects" of assignment to the diaphragm arm, adjusting for condom use in an appropriate sense. Issues raised in the MIRA trial apply to other trials of HIV prevention methods, some of which are currently being conducted or designed.