Influences of geo-spatial location on pre-exposure prophylaxis use in South Africa: positioning microbicides for better product uptake

Young women bear a disproportionately high burden of HIV infection in sub-Saharan Africa, prioritising pre-exposure prophylaxis (PrEP) can be an integral part of HIV prevention combination strategies. Women initiated HIV prevention technology options will require consistent adherence, an imperative for product effectiveness. With several PrEP clinical trials underway; exploring women’s acceptability to advances in HIV prevention technologies can better facilitate demand creation for future PrEP roll out. This study utilised the opportunity of post-trial access to CAPRISA 008 women (trial) and non-trial women from three geo-spatial settings (urban, rural and peri-urban) to identify microbicide acceptability and how product associations of microbicides can influence future HIV prevention choices. Six participatory workshops using participatory action research with art-based activities and discussion groups were conducted in KwaZulu-Natal with 104 women from various geo-spatial locations and social status to understand microbicide acceptability and product associations. The data were analysed using thematic analysis. The study found that women’s acceptability and product association of the tenofovir gel microbicide differed according to rural and urban areas. Most urban women identified confidence, sexiness and classiness as key associations that will encourage microbicide acceptability and use, while rural women identified respect, responsibility and confidence as the key product associations, with increased focus on the individual and collective family/community benefits of product acceptance and use. Urban–rural differences suggest a market segmentation that is contextualised to be locally responsive to promote HIV prevention technologies. Various sexual encounters further determined the types of HIV prevention technologies women would consider. In line with WHO’s recommendation that PrEP should be an additional prevention choice for people at risk of HIV, this study underscores the importance of user engagement, understanding product associations and how this can influence product acceptability and promotion of HIV prevention technologies.     

End-Users’ Product Preference Across Three Multipurpose Prevention Technology Delivery Forms: Baseline Results from Young Women in Kenya and South Africa

A multipurpose prevention technology (MPT) that combines HIV and pregnancy prevention is a promising women’s health intervention, particularly for young women. However, little is known about the drivers of acceptability and product choice for MPTs in this population. This paper explores approval ratings and stated choice across three different MPT delivery forms among potential end-users. The Trio Study was a mixed-methods study in women ages 18–30 that examined acceptability of three MPT delivery forms: oral tablets, injections, and vaginal ring. Approval ratings and stated choice among the products was collected at baseline. Factors influencing stated product choice were explored using multivariable multinomial logistic regression. The majority (62%) of women in Trio stated they would choose injections, 27% would choose tablets and 11% would choose the ring. Significant predictors of choice included past experience with similar contraceptive delivery forms, age, and citing frequency of use as important. Ring choice was higher for older (25–30) women than for younger (18–24) women (aRR = 3.1; p < 0.05). These results highlight the importance of familiarity in MPT product choice of potential for variations in MPT preference by age.     

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 Importance of Male Partner Involvement for Women’s Acceptability and Adherence to Female-Initiated HIV Prevention Methods in Zimbabwe

Enlisting male partner involvement is perceived as an important component of women’s successful uptake of female-initiated HIV prevention methods. We conducted a longitudinal study among a cohort of 955 Zimbabwean women participating in a clinical trial of the effectiveness of a female-initiated HIV prevention method (the diaphragm and lubricant gel) to: (a) describe the extent to which women involved their male partners in the decision to use the study products, and (b) measure the effect perceived male partner support had on their acceptability and consistent use of these methods. Reported levels of male partner involvement in discussions and decisions regarding: joining the study, study activities, the outcome of HIV/STI test results, and product use were very high. In multivariate analyses, regular disclosure of study product use and partner approval for the diaphragm and gel were significantly associated with women’s acceptability and consistent use of the products; an essential component for determining efficacy of investigational prevention methods. These results support the need for more sophisticated measurement of how couples interact to make decisions that impact study participation and investigational product use as well as more rigorous adaptations and evaluations of existing strategies to involve male partners in female-initiated HIV prevention trials.     

Enhancing Acceptability and Use of Sexual Barrier Products Among HIV Concordant and Discordant Couples

Strategies to prevent HIV transmission may benefit from addressing both individual and dyadic factors. This study compared the impact of group and individual interventions on the acceptability of sexual barrier products among HIV sero-concordant and discordant couples, and evaluated the contribution of couple members’ perceived product acceptability to their sexual barrier use. Participants (n = 216 couples) were multicultural couples in Miami, Florida. Longitudinal multilevel modeling and the actor–partner interdependence model were used for analyses. Product acceptability increased more among female group participants, and acceptability of male condoms increased more among sero-discordant couples in the group. Additionally, acceptability of products associated with prevention of STDS/HIV and pregnancy increased more among sero-concordant couples in the group condition. Both actor and partner product acceptability predicted use. Results support the use of group interventions targeting both partners in relationships in prevention programs designed to enhance sexual barrier use.     

Undergraduates' perception of HIV immunization: attitudes and behaviours as determining factors

The development of a vaccine to prevent human immunodeficiency virus (HIV) infection is a highly desirable goal. However, there may be a number of psychosocial barriers to HIV vaccine acceptance. The purpose of this study was to evaluate the relationship of health beliefs and health lifestyles to acceptability of hypothetical HIV immunization. The subjects were 549 college students who completed self-administered questionnaires that addressed health beliefs, health behaviours, and acceptability of hypothetical HIV vaccines. Results showed that all 6 variables of health beliefs, based in part on the Health Belief Model, independently predicted HIV vaccine acceptability. For the overall sample, 5 health behaviours were significantly correlated with HIV vaccination: diet, smoking, drug use, alcohol use, and prior sexual experience. The results suggest that universal HIV acceptance cannot be assumed, and that certain health beliefs and behaviours are likely to influence decisions regarding HIV immunization.     

Feasibility and acceptability of pre-exposure prophylaxis use among women in violent relationships

Intimate partner violence (IPV) is associated with a high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP), which does not require partner knowledge or consent, is a promising HIV risk reduction option for women experiencing IPV. Drawing on semi-structured interviews with 26 women experiencing IPV within the last six months, this study explored the feasibility and acceptability of PrEP use in this population. Slightly more than half of the women in this study expressed interest in taking PrEP when in a relationship with an abusive partner. Potential barriers to PrEP, discussed regardless of women's expressed interest in PrEP, included fear of side effects and long-term health concerns, low risk perceptions, potential partner interference, and prioritizing coping with the relationship over HIV prevention. When offering PrEP counseling, providers should inquire about IPV, as women in violent relationships may require tailored counseling to address barriers and concerns specific to their situation.     

Using Conjoint Analysis to Measure the Acceptability of Rectal Microbicides Among Men Who Have Sex with Men in Four South American Cities

Conjoint Analysis (CJA), a statistical market-based technique that assesses the value consumers place on product characteristics, may be used to predict acceptability of hypothetical products. Rectal Microbicides (RM)-substances that would prevent HIV infection during receptive anal intercourse-will require acceptability data from potential users in multiple settings to inform the development process by providing valuable information on desirable product characteristics and issues surrounding potential barriers to product use. This study applied CJA to explore the acceptability of eight different hypothetical RM among 128 MSM in Lima and Iquitos, Peru; Guayaquil, Ecuador; and Rio de Janeiro, Brazil. Overall RM acceptability was highest in Guayaquil and lowest in Rio. Product effectiveness had the greatest impact on acceptability in all four cities, but the impact of other product characteristics varied by city. This study demonstrates that MSM from the same region but from different cities place different values on RM characteristics that could impact uptake of an actual RM. Understanding specific consumer preferences is crucial during RM product development, clinical trials and eventual product dissemination.     

High Acceptability of a Vaginal Ring Intended as a Microbicide Delivery Method for HIV Prevention in African Women

Vaginal rings (VRs) are new methods for continuous delivery of microbicides. This is the first study to quantitatively and qualitatively explore the acceptability of rings in Africa: 157 HIV-negative, sexually active women aged 18-35 used a placebo silicone elastomer ring for 12?weeks. They completed product acceptability questionnaires every 4?weeks. We conducted 6 exit focus group discussions with a subset of 48 women and 19 in-depth interviews with male partners. Retention in the study was high (97?%). Initial insertion at the clinic was successful on first attempt for 81?% of participants. Most women were comfortable using the ring, and very few (≤2?%) could feel it during daily activities or had ring-related physical or emotional problems. In the qualitative interviews many participants reported that they initially had concerns about using the ring. However, only a minority of women actually reported concerns with the ring during the study. The most frequent concern was that the ring would get lost inside the body (20?%), and this was significantly correlated with study site, frequently thinking about the ring and reporting that the ring was not very easy to remove. Qualitative data suggest that informants grew to like the ring because it felt securely placed, was unnoticeable during daily activities, and felt "normal" during sex. The ring appeared to be highly acceptable for women and men. Initial concerns with this novel method suggest a need for enhanced product counseling when VRs are introduced.     

Exploring diaphragm use as a potential HIV prevention strategy among women in the United States at risk.

Given the immediate need for physical cervical barrier methods like the diaphragm to protect against HIV/STIs, understanding what factors influence the acceptability of these products and how to overcome obstacles to their use is important. We explored perceptions of the diaphragm and factors that might enhance its acceptability in 25 focus groups with racially/ethnically diverse young women in the U.S. at risk for HIV/STIs (N = 140). Women believed the diaphragm has positive attributes, and most indicated they would be more likely to use the diaphragm if they were confident they could use it correctly and it protected against HIV. They also considered it messy to use and difficult to insert or remove. Findings suggest that the diaphragm could be a desirable option for pregnancy and disease prevention for some women at risk for HIV/STIs. Although disadvantages to diaphragm use were identified, many could be eliminated through changes in product design and provider intervention.     

Adherence and Acceptability in MTN 001: A Randomized Cross-Over Trial of Daily Oral and Topical Tenofovir for HIV Prevention in Women

We compared adherence to and acceptability of daily topical and oral formulations of tenofovir (TFV) used as pre-exposure prophylaxis (PrEP) for HIV prevention among women in South Africa, Uganda and the United States. 144 sexually active, HIV-uninfected women participated in a cross-over study of three regimens: oral tablet, vaginal gel, or both. We tested for differences in adherence and evaluated product acceptability. Self-reported adherence for all regimens was high (94 %), but serum TFV concentrations indicated only 64 % of participants used tablets consistently. Most women in the U.S. (72 %) favored tablets over gel; while preferences varied at the African sites (42 % preferred gel and 40 % tablets). Findings indicate a role for oral and vaginal PrEP formulations and highlight the importance of integrating pharmacokinetics-based adherence assessment in future trials. Biomedical HIV prevention interventions should consider geographic and cultural experience with product formulations, partner involvement, and sexual health benefits that ultimately influence use.     

Impact of the Dapivirine Vaginal Ring on Sexual Experiences and Intimate Partnerships of Women in an HIV Prevention Clinical Trial: Managing Ring Detection and Hot Sex

Vaginally-inserted HIV prevention methods have been reported to impact the sexual experience for women and their partners, and hence impacts acceptability of and adherence to the method. We analyzed in-depth interviews and focus group discussions about participants’ sexual experiences while wearing the ring, collected during the MTN-020/ASPIRE phase 3 safety and effectiveness trial of a dapivirine vaginal ring for HIV prevention in Malawi, South Africa, Uganda, and Zimbabwe. Most women reported that partners did not feel the ring during sex, however, women felt they had to manage their partners’ interaction with or reaction to the ring. In maintaining positive relationships, women were concerned about partners’ discovering ring use and about ensuring that partners had a good sexual experience with them. Finally women were concerned about how they themselves experienced sex with the ring. Some found that the ring made the vaginal environment more desirable for their partners and themselves.     

Rectal Microbicides: Can We Make Them and Will People Use Them?

The results of the CAPRISA 004 and iPrEx HIV prevention studies have demonstrated that topical or systemic use of antiretroviral agents can significantly reduce the risk of HIV acquisition associated with unprotected vaginal or anal sexual intercourse. However, the effect size in these studies was relatively modest and product adherence was generally poor. These observations suggest the need for new approaches to HIV prevention, especially for high risk MSM. Rates of lubricant use are high in MSM practicing receptive anal sex. Consequently, the development of an antiretroviral rectal microbicide gel may provide a safe and effective means of preventing HIV infection with an intervention that is likely to have high acceptability among the target population. The purpose of this article is to describe the challenges and progress in the development of rectal microbicides for HIV prevention.     

Rectal microbicides: can we make them and will people use them?

The results of the CAPRISA 004 and iPrEx HIV prevention studies have demonstrated that topical or systemic use of antiretroviral agents can significantly reduce the risk of HIV acquisition associated with unprotected vaginal or anal sexual intercourse. However, the effect size in these studies was relatively modest and product adherence was generally poor. These observations suggest the need for new approaches to HIV prevention, especially for high risk MSM. Rates of lubricant use are high in MSM practicing receptive anal sex. Consequently, the development of an antiretroviral rectal microbicide gel may provide a safe and effective means of preventing HIV infection with an intervention that is likely to have high acceptability among the target population. The purpose of this article is to describe the challenges and progress in the development of rectal microbicides for HIV prevention.     

Acceptability of tenofovir gel as a vaginal microbicide by US male participants in a Phase I clinical trial (HPTN 050)

We studied the acceptability of tenofovir gel among HIV-infected and uninfected men who were exposed to it during vaginal intercourse. The gel was found to be highly acceptable to most men, the large majority indicating they would probably use it in the future if they were concerned about HIV and the product were available. Men liked the gel's transparency and odorless qualities, although reactions to its viscosity were more varied. Men acknowledged women's rights to self-determination concerning HIV-prevention, yet considered that women's covert use of the product was more acceptable in the context of 'one-night-stands' than in stable relationships, for which dialogue on protection measures was preferred. Restrictions to couples' habitual sexual repertoire and the protocol requirement to use condoms resulted in complaints. Microbicide trials that do not require condom use from men who don't typically use them may provide a more accurate assessment of acceptability. Consistent microbicide use may be contingent on its ease of incorporation into typical sexual practices, type of sexual partnership and contextual issues.     

Adherence and Acceptability of a Multidrug Vaginal Ring for HIV Prevention in a Phase I Study in the United States

We evaluated the adherence and acceptability of a vaginal ring containing dapivirine, maraviroc, or both drugs for 28 days during a Phase I placebo-controlled trial in 48 HIV-negative sexually abstinent U.S. women aged 18–40. Adherence was assessed weekly by clinical interview and computer-assisted self-interviewing; acceptability assessment occurred at the last product-use visit. Study retention was 98 % (47/48); 94 % (45/48) reported being fully adherent with ring use during the 28-day period. Two participants experienced the ring partially coming out. Analysis was blinded and behavioral data were combined across study groups. Most women reported being very comfortable having the ring in their vagina; 44 % preferred continuous use, whereas 51 % had no preference compared to episodic use. Although a range of minor ring concerns were expressed, few were actually experienced. High adherence to and acceptability of this vaginal ring in this Phase I trial contributes to its promise as a sustained mechanism for multidrug vaginal microbicide delivery.     

Differences in HIV vaccine acceptability between genders

The development of safe and efficacious preventive HIV vaccines offers the best long-term hope of controlling the AIDS pandemic. Nevertheless, suboptimal uptake of safe and efficacious vaccines that already exist suggest that HIV vaccine acceptability cannot be assumed, particularly among communities most vulnerable to HIV. The present study aimed to identify barriers and motivators to future HIV vaccine acceptability among low socioeconomic, ethnically diverse men and women in Los Angeles County. Participants completed a cross-sectional survey assessing their attitudes and beliefs regarding future HIV vaccines. Hypothetical HIV vaccine scenarios were administered to determine HIV vaccine acceptability. Two-sided t-tests were performed, stratified by gender, to examine the association between vaccine acceptability and potential barriers and motivators. Barriers to HIV vaccine acceptability differed between men and women. For women, barriers to HIV vaccine acceptability were related to their intimate relationships (p<0.05), negative experiences with health care providers (p<0.05) and anticipated difficulties procuring insurance (p<0.01). Men were concerned that the vaccine would weaken the immune system (p<0.005) or would affect their HIV test results (p<0.05). Motivators for women included the ability to conceive a child without worrying about contracting HIV (p<0.10) and support from their spouse/significant other for being vaccinated (p<0.10). Motivators for men included feeling safer with sex partners (p<0.05) and social influence from friends to get vaccinated (p<0.005). Family support for HIV immunization was a motivator for both men and women (p<0.10). Gender-specific interventions may increase vaccine acceptability among men and women at elevated risk for HIV infection. Among women, interventions need to focus on addressing barriers due to gendered power dynamics in relationships and discrimination in health care. Among men, education that addresses fears and misconceptions about adverse effects of HIV vaccination on health and the importance of vaccination as one component of integrated HIV prevention may increase vaccine acceptability.     

Reasons People Give for Using (or Not Using) Condoms

Study participants (N = 348) were asked about 46 reasons that have been suggested for why people use or do not use condoms. Participants were asked which of these reasons motivated them when they were deciding whether to use condoms in 503 sexual relationships. Participants were classified into one of three roles based on their HIV status and the status of each sexual partner: HIV+ people with HIV? partners; HIV? people with HIV+ partners; and HIV? people with HIV? partners. Motivations were looked at in the context of each of these roles. Of the 46 reasons, only 15 were selected by at least 1/3 of the participants, and only seven were selected by at least half. Frequently reported reasons primarily concern protecting self and partner from STDs including HIV. Less frequently reported reasons involved social norms, effects of condoms on sex, and concern for the relationship. These findings have implications for clinical interventions.     

HIV pre-exposure prophylaxis (PrEP) awareness and acceptability among trans women: a review

ABSTRACT

Transgender (trans) women are disproportionally burdened by the HIV epidemic due to complex structural, psychosocial and biological factors. HIV pre-exposure prophylaxis (PrEP) is a biomedical prevention approach for people at substantial risk of acquiring HIV. This literature review assessed awareness, willingness to use, and barriers and facilitators for PrEP acceptability among trans women. A search was conducted through five databases and included studies with primary data and disaggregate results for trans women. Of 255 retrieved citations, 17 met the inclusion criteria and were included. Low to moderate knowledge about PrEP was observed among studies. However, willingness to use PrEP was predominantly high. Frequent barriers to PrEP acceptability included concerns about side effects, cost, hormone therapy, adherence, PrEP-related stigma and interaction with healthcare workers. Facilitators included perceived reduction of HIV risk, fear of HIV/AIDS and reduced dependence on partners. Findings suggest elevated interest in PrEP and highlight important barriers and facilitators that should be specifically addressed to optimize PrEP uptake and use among this highly vulnerable population.     

Trial participation disclosure and gel use behavior in the CAPRISA 004 tenofovir gel trial

Disclosure, or open communication, by female microbicide trial participants of their trial participation and use of an investigational HIV prevention drug to a sexual partner may affect participants' trial product usage behavior and contribute to poor adherence. With mixed results from recent microbicide clinical trials being linked to differing participant adherence, insights into the communication dynamics between trial participants and their sexual partners are particularly important. We examined the quantitative association between (1) communication of trial participation to a partner and participant adherence to gel and (2) communication of trial participation to a partner and participant HIV status. An in-depth adherence and product acceptability assessment was administered to the women participating in the CAPRISA 004 trial. Additionally, we collected qualitative data related to communication of trial participation and gel use. Qualitatively, among 165 women who had reported that they had discussed trial participation with others, most (68%) stated that they communicated participation to their sexual partner. Most of the women who had communicated study participation with their partners had received a positive/neutral response from their partner. Some of these women stated that gel use was easy; only a small number said that gel use was difficult. Among women who did not communicate their study participation to their partners, difficulty with gel use was more common and some women stated that they feared communicating their participation. Quantitatively, there was no statistically significant difference in the proportions of women who had communicated study participation to a partner across different adherence levels or HIV status. A deeper knowledge of the dynamics surrounding trial participation communication to male partners will be critical to understanding the spectrum of trial product usage behavior, and ultimately to designing tailored strategies to assist trial participants with product adherence.