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

<p>Abstract</p> <p>Background</p> <p>We 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.</p> <p>Methods</p> <p>Our 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.</p> <p>Results and discussion</p> <p>In 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.</p> <p>Conclusions</p> <p>High 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.</p

Consistent use of a combination product versus a single product in a safety trial of the diaphragm and microbicide in Harare, Zimbabwe.

BACKGROUND: We examined the use and acceptability of a combination product (diaphragm and gel) compared to a single product (gel) during a 6-month safety trial in Zimbabwe. STUDY DESIGN: Women were randomized to the use of a diaphragm with gel or the use of gel alone, in addition to male condoms. Ever use and use of study product on the last act of sexual intercourse were assessed monthly by Audio Computer-Assisted Self-Interviewing. Acceptability, correct use and consistent use (use at every sexual act during the previous 3 months) were measured on the last visit by face-to-face interview. Predictors of consistent use were examined using multivariate logistic regression analyses. RESULTS: In this sample of 117 sexually active, monogamous, contracepting women, rates of consistent use were similar in both groups (59.7% for combination method vs. 56.4% for gel alone). Product acceptability was high, but was not independently associated with consistent use. Independent predictors of consistent use included age [adjusted odds ratio (AOR)=1.08; 95% confidence interval (95% CI)=1.01-1.16], consistent condom use (AOR=3.85; 95% CI=1.54-9.63) and having a partner who approves of product use (AOR=2.66; 95% CI=1.10-6.39). CONCLUSIONS: Despite high reported acceptability and few problems with the products, the participants reported only moderate product adherence levels. Consistent use of condoms and consistent use of products were strongly associated. If observed in other studies, this may bias the estimation of product effectiveness in future trials of female-controlled methods

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

This is the detailed technical report that accompanies the paper “Analyzing Direct Effects in Randomized Trials with Secondary Interventions: An Application to HIV Prevention Trials” (an unpublished, technical report version of which is available online at http://www.bepress.com/ucbbiostat/paper223). The version here gives full details of the models for the time-dependent analysis, and presents further results in the data analysis section. 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

Pregnant and breastfeeding women's prospective acceptability of two biomedical HIV prevention approaches in Sub Saharan Africa : a multisite qualitative analysis using the theoretical framework of acceptability

HIV infection during pregnancy and breastfeeding has implications for maternal health. Between May- November 2018, we explored prospective acceptability of two novel HIV Pre-exposure Prophylaxis (PrEP) products, oral pills and vaginal rings, through focus group discussions with 65 pregnant and breastfeeding women in Malawi, South Africa, Uganda, Zimbabwe. Qualitative analysis was completed, guided by the Theoretical Framework of Acceptability (TFA). First, a deductive thematic analysis was applied to relevant coded data, into the seven TFA constructs (Affective Attitude; Burden; Ethicality, Intervention Coherence; Opportunity Costs; Perceived Effectiveness; Self-efficacy). Next, an iterative analysis was completed to generate themes within each of the TFA constructs. Women’s positive attitudes towards daily oral PrEP highlighted the familiarity of taking pills, understanding the purpose of taking pills, and the perception that it is an effective method to protect mothers and babies from HIV during pregnancy and breastfeeding. Women emphasized the ease of using the ring given its monthly duration that lowers burden on the user, its discreetness and invisibility once in place. The TFA analysis highlighted how acceptability of both methods could be enhanced by focusing on perceptions of the end users (i.e. the women) and not just the products themselves. This approach provided insights into how to refine the intervention materials and plans for implementation

Acceptability and Use of the Diaphragm and Replens® Lubricant Gel for HIV Prevention in Southern Africa

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

Association of sexual relationship power with PrEP persistence and other sexual health outcomes among adolescent and young women in Kenya and South Africa

IntroductionGendered power inequalities impact adolescent girls’ and young women's (AGYW) sexual and reproductive health (SRH) outcomes. We investigated the influence of sexual relationship power on AGYW's SRH outcomes, including HIV pre-exposure prophylaxis (PrEP) persistence.MethodsThe POWER study in Kisumu, Kenya, and Cape Town and Johannesburg, South Africa provided PrEP to 2,550 AGYW (aged 16–25). AGYW's perceived power in their primary sexual relationship was measured among the first 596 participants enrolled using the Sexual Relationship Power Scale's (SRPS) relationship control sub-scale. Multivariable regression was used to test for (1) key sociodemographic and relationship characteristics associated with relationship power; and (2) the association of relationship power with SRH outcomes including PrEP persistence.ResultsIn this cohort, the mean SRPS score was 2.56 (0.49), 542 (90.9%) initiated PrEP; 192 (35.4%) persisted with PrEP at 1 month of which 46 (24.0% of 192) persisted at 6 months. SRPS were significantly lower among AGYW who cohabited with their sex partner (−0.14, 95% CI: −0.24 to −0.04, p = 0.01), or had ≥1 sex partner (−0.10, 95% CI: −0.19 to −0.00, p = 0.05). AGYW with lower SRPS were more likely to not know their partner's HIV status (aOR 2.05, 95% CI: 1.27 to 3.33, p &lt; 0.01), but SRPS was not associated with PrEP persistence, STI infection, condom, or hormonal contraception use.DiscussionAGYW's reasons for initiating PrEP and reasons for continuously using PrEP may be different. While low relationship power was associated with perceived HIV vulnerability, AGYW's PrEP persistence may be influenced by more than relationship power

Biomarker Validation of Reports of Recent Sexual Activity: Results of a Randomized Controlled Study in Zimbabwe

Challenges in the accurate measurement of sexual behavior in human immunodeficiency virus (HIV) prevention research are well documented and have prompted discussion about whether valid assessments are possible. Audio computer-assisted self-interviewing (ACASI) may increase the validity of self-reported behavioral data. In 2006–2007, Zimbabwean women participated in a randomized, cross-sectional study that compared self-reports of recent vaginal sex and condom use collected through ACASI or face-to-face interviewing (FTFI) with a validated objective biomarker of recent semen exposure (prostate-specific antigen (PSA) levels). Of 910 study participants, 196 (21.5%) tested positive for PSA, an indication of semen exposure during the previous 2 days. Of these 196 participants, 23 (11.7%) reported no sex in the previous 2 days, with no difference in reported sexual activity between interview modes (12.5% ACASI vs. 10.9% FTFI; Fisher's exact test: P = 0.72). In addition, 71 PSA-positive participants (36.2%) reported condom-protected vaginal sex only; their reports also indicated no difference between interview modes (33.7% ACASI vs. 39.1% FTFI; P = 0.26). Only 52% of PSA-positive participants reported unprotected sex during the previous 2 days. Self-report was a poor predictor of recent sexual activity and condom use in this study, regardless of interview mode, providing evidence that such data should be interpreted cautiously