Helen Cheng

The Diaphragm and Lubricant Gel for Prevention of Cervical Sexually Transmitted Infections: Results of a Randomized Controlled Trial

Background 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. Methods 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. Findings 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). Interpretation 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. Trial Registration ClinicalTrials.gov NCT00121459 [NCT00121459]

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 partners 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 womens decisions about disclosure.

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

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.

Promethazine misuse among methadone maintenance patients and community-based injection drug users.

Objective:Promethazine has been reported to be misused in conjunction with opioids in several settings. Promethazine misuse by itself or in conjunction with opioids may have serious adverse health effects. To date, no prevalence data for the nonmedical use of promethazine have been reported. This study examines the prevalence and correlates of promethazine use in 2 different populations in San Francisco, California: methadone maintenance clinic patients and community-based injection drug users (IDUs). Methods:We analyzed urine samples for the presence of promethazine and reviewed the clinical records for 334 methadone maintenance patients at the county methadone clinic. Separately, we used targeted sampling methods to recruit and survey 139 community-based opioid IDUs about their use of promethazine. We assessed prevalence and factors associated with promethazine use with bivariate and multivariate statistics. Results:The prevalence of promethazine-positive urine samples among the methadone maintenance patients was 26%. Only 15% of promethazine-positive patients had an active prescription for promethazine. Among IDUs reporting injection of opiates in the community-based survey, 17% reported having used promethazine in the past month; 24% of the IDUs who reported being enrolled in methadone treatment reported using promethazine in the past month. Conclusions:The finding that one-quarter of methadone maintenance patients in a clinic or recruited in community settings have recently used promethazine provides compelling evidence of significant nonmedical use of promethazine in this patient population. Further research is needed to establish the extent and nature of nonmedical use of promethazine.

Diaphragm and lubricant gel acceptance, skills and patterns of use among women in an effectiveness trial in Southern Africa

Objectives We examined diaphragm and gel-related skills, patterns of use, and problems, among women who participated in the MIRA study, a multisite phase III diaphragm trial in Zimbabwe and South Africa. Methods We evaluated whether baseline characteristics were associated with the ability to correctly insert/remove the diaphragm prior to randomisation by means of multivariate logistic regression modeling. Employing face-to-face interviews with intervention arm participants, patterns of use and comfort using the products were measured at Month 3 and Exit, and reported problems with the products were assessed quarterly. Results At baseline, 72.5% of women correctly inserted/removed the diaphragm within one attempt, and this skill was most strongly associated with the Johannesburg study site. At exit, over 90% of intervention women were very comfortable inserting, wearing, cleaning and removing the diaphragm; however, 31.8% reported usual removal of the diaphragm before the prescribed six hours after sex. During the 12–24 month follow-up period there were only 133 (<1%) reported problems with the diaphragm and gel over 14,544 follow-up visits. Conclusions Diaphragm skills were easily acquired and few problems were reported during the course of the trial. Reviving the diaphragm as a contraceptive option or as a reusable microbicide delivery mechanism seems feasible in these settings.

Non-Partner Violence Against Women Who Use Drugs in San Francisco

This article examines non-partner violence among women who use methamphetamine (N = 322), recruited in an inner-city neighborhood of San Francisco. The combined prevalence of non-partner physical or sexual violence in the past 6 months was 28%, roughly equal to the prevalence of partner violence (26%). In multivariate analysis, factors associated with non-partner violence included frequent subsistence difficulty (adjusted odds ratio [AOR] = 2.43, 95% confidence interval [CI] = [1.3, 4.6]) and sex trade (AOR = 2.27, 95% CI = [1.4, 4.1]). Having a steady male partner was not protective against non-partner violence. Violence perpetrated by non-partners should be considered when assessing social and structural factors that influence women’s health.

Examining the Associations Between Sex Trade Involvement, Rape, and Symptomatology of Sexual Abuse Trauma:

The high prevalence of rape and sexual trauma symptomatology among women involved in street-based sex trades is well-established. Because prior research has lacked appropriate, non-sex trade involved comparison groups, it is unknown whether differences exist among similarly situated women who do and do not trade sex. This article explores experiences of childhood and adult rape and symptomatology of sexual abuse trauma among a community-based sample of 322 women who use methamphetamine in San Francisco, California, 61% of whom were involved in the sex trade. Study participants were recruited via respondent-driven sampling and eligible if they were cisgender women, aged 18 or older, current methamphetamine users, and sexually active with at least one cisgender man in the past 6 months. The dependent variable was sexual abuse trauma symptomatology, as measured by the Sexual Abuse Trauma Index (SATI) subscale of the Trauma Symptom Checklist–40 (TSC-40), and the explanatory variable was sex trade involvement. Potential covariates were age, current homelessness, methamphetamine dependence, and experiences of childhood and adult rape. Sixty-one percent of participants had a SATI subscale score suggestive of sexual abuse trauma. The overall prevalence of rape in childhood and adulthood was 52% and 73%, respectively. In bivariate analysis, sex trade involvement and all of the potential covariates except for homelessness and age were associated with a SATI score suggestive of sexual abuse trauma. In multivariate models controlling for significant covariates, there was no longer a statistically significant association between sex trade involvement or childhood rape and an elevated SATI score. Elevated levels of psychological dependence on methamphetamine and experiences of rape as an adult were still associated with a high SATI score. These findings highlight that urban poor women, regardless of sex trade involvement, suffer high levels of rape and related trauma symptomatology.

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

Background 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 Methods 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. Purpose 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. Results 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. Limitations The program began after most participants had exited from the MIRA trial and required re-contacting women, resulting in difficulty in locating some participants. Conclusions 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

What’s Faith Got to Do with It? Religiosity Among Women Who Use Methamphetamine

Religiosity is not found to be consistently protective in mental health and substance use outcomes among illicit drug users. This study examines the association among religiosity, mental health, and drug use among a community-recruited sample of women who use methamphetamine. The majority of the sample (74%) had high scores of religious faith. In multivariate analysis, those with high scores had higher odds of self-reporting a mental health diagnosis and of being psychologically dependent on methamphetamine, and they were less likely to report injection risk. Further examination of the role of religiosity in the lives of women who use methamphetamine is advised.

How Presentation of Drug Detection Results Changed Reports of Product Adherence in South Africa, Uganda and Zimbabwe

Accurate estimates of study product use are critical to understanding and addressing adherence challenges in HIV prevention trials. The VOICE trial exposed a significant gap between self-reported adherence and drug detection. The VOICE-D qualitative study was designed to better understand non-adherence during VOICE, and was conducted in 2 stages: before (stage 1) and after (stage 2) drug detection results were provided to participants. Transcripts from 44 women who participated in both stages were analysed to understand the effect of presenting drug detection data on narratives of product use. Thirty-six women reported high adherence in stage 1, yet admitted non-use in stage 2, three reported high adherence in both stages (contrary to their drug detection results) and five had consistent responses across both stages and drug results. Presenting objective measures of use may facilitate more accurate product use reporting and should be evaluated in future prevention trials.