Erica L. Gollub

Commentary: methods women can use that may prevent sexually transmitted disease, including HIV.

Although sexually transmitted diseases, including human immunodeficiency virus (HIV), are a major concern for women, few prevention messages are targeted specifically to women. Those that are generally stress abstaining, altering the number or selection of partners, and urging partners to use condoms. But these behaviors may be unrealistic for many women, particularly women who are at highest risk for sexually transmitted diseases, because they require significant changes in life-style or depend on male-controlled condom use. Recommendation of contraceptives for prevention of sexually transmitted diseases depends largely on how well specific methods perform under controlled conditions, either in the laboratory or in clinical trials. Observational studies, which better reflect day-to-day use, indicate that condoms, barriers, and spermicides, used properly and consistently, can provide substantial protection against various sexually transmitted diseases. Condoms can similarly help protect against HIV, but studies of barriers and spermicides are scant and currently inconclusive. Finally, those methods that are controlled by women are consistently more effective in preventing sexually transmitted diseases. Thus, although condoms used well are still the best choice, the imperative for female-controlled methods indicates that diaphragms and spermicides should receive greater emphasis in prevention messages.

Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women.

Background Data are limited on the female condom’s effectiveness against STDs. Goal The goal was to compare STD rates between women given small-group education on, and free supplies of, either female or male condoms. Study Design Female patients at an STD clinic (n = 1442) were randomly assigned to condom type and followed via medical records for STDs (gonorrhea, chlamydia, early syphilis, or trichomoniasis). Results In an intention-to-treat analysis, the odds ratio for a comparison of STD occurrence between the female and male condom groups was 0.75 (95% confidence interval [CI], 0.56–1.01), and it did not change with adjustment. In a second analysis among women returning for subsequent screening, incidence rates for the first new postintervention STD per 100 woman-months of observation were 6.8 in the female condom group and 8.5 in the male condom group (rate ratio = 0.79 [CI, 0.59–1.06]). Conclusion Compared with those provided with male condoms alone, women counseled on, and provided with, female condoms fared no worse and experienced a nonsignificant reduction in STDs.

Short-term acceptability of the female condom among staff and patients at a New York City Hospital.

An acceptability study of the female condom undertaken at New Yorks Harlem Hospital between August 1993 and February 1994 enrolled 52 women aged 18-57, 41 of whom (79%) used the female condom at least once. Of these, one-half used the female condom at least three times and 40% used it once; on average, women used it 2.4 times. Two-thirds of users liked the female condom either very much or somewhat, 20% were neutral and 15% stated that they did not like it. One-half of the women reported that their partner liked the device, while 17% said he felt neutral about it and approximately one-quarter said he disliked it. Seventy-three percent of respondents and 44% of their partners preferred the female condom to the male condom.

Male-condom and female-condom use among women after counseling in a risk-reduction hierarchy for STD prevention.

Background: A concern with hierarchy messages, which promote male condoms and female‐controlled barrier methods along a prevention continuum, is that they may discourage condom use. Goal: To measure male‐condom and female‐condom use among women who received hierarchy counseling and compare this with women counseled about condoms only. Study Design: Three observational cohorts that correspond to prevention message received were assembled, and consisted of female sexually transmitted disease clinic patients who were counseled about male condoms, female condoms, or a hierarchy message. The hierarchy message promoted male and female condoms, the diaphragm and cervical cap, spermicides, and withdrawal, in descending order of effectiveness against sexually transmitted diseases. After counseling, women were interviewed and returned for follow‐up visits at 2 weeks, 4 months, and 6 months. The outcome was the mean proportion of male condom‐ or female condom‐protected coital acts at each follow‐up visit in the hierarchy cohort. The outcome was dichotomized as high (≥ 70% of coital acts protected) or low (< 70%), and generalized estimating equations were used to compare observed follow‐up condom use with baseline within the hierarchy cohort and observed follow‐up condom use between cohorts. It was assumed that condom use in persons not present at 6 months was equal to baseline levels, and condom use estimates were calculated for each full cohort that was initially enrolled. Results: The mean proportion of condom‐protected coital acts in the hierarchy cohort was significantly increased from baseline at each follow‐up visit. There were no differences in observed condom use during follow up between the hierarchy cohort and either the male‐condom or the female‐condom cohort. However, when the full cohort initially enrolled was considered, 6‐month condom use was significantly higher in the hierarchy cohort than in the male‐condom cohort. Conclusion: Hierarchy counseling was associated with a significant increase in condom use. Our findings suggest that offering a choice of male and female condoms results in increased protection over counseling in male condoms alone.

Living with Uncertainty: Acting in the Best Interests of Women

A recent multi-country study on hormonal contraceptives (HC) and HIV acquisition and transmission among African HIV-serodiscordant couples reported a statistically significant doubling of risk for HIV acquisition among women as well as transmission from women to men for injectable contraceptives. Together with a prior cohort study on African women seeking health services, these data are the strongest yet to appear on the HC-HIV risk. This paper will briefly review the Heffron study strengths and relevant biological and epidemiologic evidence; address the futility of further trials; and propose instead an alternative framework for next steps. The weight of the evidence calls for a discontinuation of progestin-dominant methods. We propose here five types of productive activities: (1) scaling injectable hormones down and out of the contraceptive mix; (2) strengthening and introducing public health strategies with proven potential to reduce HIV spread; (3) providing maximal choice to reduce unplanned pregnancy, starting with quality sexuality education through to safe abortion access; (4) expanding provider training, end-user counseling and access to male and female barriers, with a special renewed focus on female condom; (5) initiating a serious research agenda to determine anti-STI/HIV potential of the contraceptive cervical cap. Trusting women to make informed choices is critical to achieve real progress in dual protection.

Correlates of Trichomonas Prevalence Among Street-Recruited, Drug-Using Women Enrolled in a Randomized Trial

Objectives. Substance-using women need prevention technologies and programs to reduce risk of HIV/sexually transmitted infection (STI). We examined STI prevalence and identified risk correlates for female drug users. Methods. We used interviewer-administered and computer-assisted surveys, and tested specimens for four, treatable STIs (trichomonas, early syphilis, gonorrhea, chlamydia) on 198 HIV-seronegative, street-recruited, substance-using women enrolled in a randomized trial to reduce HIV/STI risk. Results. Most women were crack users (88%), reported sex exchange (80%) and were not in drug user treatment (74%). Two-thirds were African-American and nearly all were unemployed. Protection during sex was infrequent. African-American women reported fewer unprotected sex acts and fewer sexual partners, but greater crack use and more sex-for exchange, than whites or Hispanics. Trichomonas prevalence (36.9%) exceeded that for chlamydia (3.5%), syphilis (1.5%), and gonorrhea (0%). In multivariate logistic regression, having a primary and casual partner more than doubled (AOR 2.86) the risk of having trichomonas and being African-American raised the risk by more than 8 times (AOR 8.45). Conclusions. African-American, drug-using women, and women with multiple partner types, are in urgent need of effective STI/HIV prevention interventions.

Basic body knowledge in street-recruited, active drug-using women enrolled in a “body empowerment” intervention trial

Background: Drug-using women remain at high risk for HIV infection. Female condoms (FC) have proven potential and cervical barriers have promise to reduce HIV risk; their effective use may be boosted by familiarity and confidence about female anatomy. Women with high levels of crack cocaine use were assessed for their knowledge about reproductive anatomy, HIV/STI risk, as well as cancer screening behaviors. Methods: Women were recruited for a randomized trial of a behavioral intervention via mobile vans in Philadelphia known for high crack use and sex exchange. Knowledge and behavioral data on 198 women were collected via interviewer-administered questionnaire. Women were randomized into control (n=99) and intervention (n=99) arms. Five weekly, small-group, intervention sessions stressed “body empowerment” and teaching use of female-initiated barrier methods. Follow-up body knowledge data were collected at 12 months. Changes in and correlates of body knowledge were analyzed and compared. Results: Most participants were African-American (66%); their mean age was 39.6 years. At baseline, 44% of the sample erroneously believed women have sex and urinate from the same place; 62% erroneously believed that tampons could get lost in the abdominal cavity. Only 27% knew douching increased STI transmission risk; only 10% knew condoms reduce cervical cancer risk. At follow-up, overall body knowledge improved substantially, across both arms. Race was associated with high body knowledge at baseline but not at follow-up. Conclusions: Knowledge favoring use of women-initiated methods and cervical cancer prevention was very low in this hard-to-reach sample. Body knowledge improved substantially with enhanced voluntary counseling and testing (VCT) as well as the women-focused intervention. Body knowledge education must be targeted and tailored to drug-using women.

Research on hormonal contraception and HIV.

304 www.thelancet.com Vol 383 January 25, 2014 Available long-acting reversible contraceptives (LARC)—intrauterine devices, implant, injections, patches— are numerous and highly effi cacious against pregnancy. Under ideal conditions of access and quality counselling, they give women the power to control fertility to an extent barely imagined by previous generations. Nevertheless, none of them protect against HIV. In their Comment, Lauren Ralph and colleagues integrate this tragic circumstance into their reasoning and recommendations, whereas this theme is given less emphasis by Ward Cates advocating for a randomised controlled trial between these effective contraceptives. Thus, these two very infl uential and experienced parties debate the ethics and feasibility of carrying out a formal trial to estimate the additional risk of HIV infection incurred by users of depot medroxyprogesterone acetate (DMPA) versus other LARCs, with Ralph and colleagues downplaying its importance compared with Cates. We agree with Ralph and colleagues on the diffi culties involved in a trial; moreover, pilot studies do not promise uniform enrolment across sites (44% in Brazil, 69% in Vietnam, 72% in Guatemala , and 82% in Egypt), and at least two studies show more dropouts in DMPA users than in users of other LARCs. Nor are there any possibilities of blinding—neither among those enrolled in the trial, nor among those assessing adherence. Moreover, recent analyses of the behavioural demands that affect adherence certainly emphasise caution. Like Ralph and colleagues, we think it is more important to improve the options and coverage for HIV protection, achieved via exploring further oral or vaginal methods, and expanding access and improving adherence to male or female condom. We should focus on these questions and accept as inevitable a level of uncertainty about DMPA, as other LARCs with a better safety profi le are developed. 20 times more eff ective in preventing unintended pregnancy than are DMPA and oral contraceptive pills. Women in countries with high HIV incidence need access to eff ective contraception and protection against HIV infection. We should simultaneously advance family planning programmes and assure these newer, more effective methods are as safe or safer than are other methods they might replace. The ambiguity of the current situation has left policy makers in countries with high HIV incidence unsure about the safety of continuing to provide DMPA. Any alleged increased risk associated with hormonal methods could be due to a combination of selection bias, diff erent condom usage, or other fl aws inherent to observational research. A randomised controlled trial off ers the best hope to fi nd out which of the most eff ective contraceptive methods might lead to the lowest risk of HIV acquisition.

Knowledge, attitudes, practices and behaviors associated with female condoms in developing countries: a scoping review

Women in developing countries are at high risk of HIV, sexually transmitted infections, and unplanned pregnancy. The female condom (FC) is an effective dual protective method regarded as a tool for woman’s empowerment, yet supply and uptake are limited. Numerous individual, socioeconomic, and cultural factors influence uptake of new contraceptive methods. We reviewed studies of FC knowledge, attitudes, practices, and behaviors across developing countries, as well as available country-level survey data, in order to identify overarching trends and themes. High acceptability was documented in studies conducted in diverse settings among male and female FC users, with FCs frequently compared favorably to male condoms. Furthermore, FC introduction has been shown to increase the proportion of “protected” sex acts in study populations, by offering couples additional choice. However, available national survey data showed low uptake with no strong association with method awareness, as well as inconsistent patterns of use between countries. We identified a large number of method attributes and contextual factors influencing FC use/nonuse, most of which were perceived both positively and negatively by different groups and between settings. Male partner objection was the most pervasive factor preventing initial and continued use. Importantly, most problems could be overcome with practice and adequate support. These findings demonstrate the importance of accounting for contextual factors impacting demand in FC programming at a local level. Ongoing access to counseling for initial FC users and adopters is likely to play a critical role in successful introduction.

Hormonal contraceptive use and women's risk of HIV acquisition: priorities emerging from recent data.

Purpose of review Understanding whether hormonal contraception increases womens risk of HIV acquisition is a public health priority. This review summarizes recent epidemiologic and biologic data, and considers the implications of new evidence on research and programmatic efforts. Recent findings Two secondary analyses of HIV prevention trials demonstrated increased HIV risk among depot medroxyprogesterone acetate (DMPA) users compared with nonhormonal/no method users and norethisterone enanthate (NET-EN) users. A study of women in serodiscordant partnerships found no significant association for DMPA or implants. Two meta-analyses found elevated risks of HIV among DMPA users compared with nonhormonal/no method users, with no association for NET-EN or combined oral contraceptive pills. In-vitro and animal model studies identified plausible biological mechanisms by which progestin exposure could increase risk of HIV, depending on the type and dose of progestin, but such mechanisms have not been definitively observed in humans. Summary Recent epidemiologic and biologic evidence on hormonal contraception and HIV suggests a harmful profile for DMPA but not combined oral contraceptives. In limited data, NET-EN appears safer than DMPA. More research is needed on other progestin-based methods, especially implants and Sayana Press. Future priorities include updating modeling studies with new pooled estimates, continued basic science to understand biological mechanisms, expanding contraceptive choice, and identifying effective ways to promote dual method use.