Acceptability of an automated directly observed therapy (DOT) application for PrEP adherence support among young men who have sex with men: a qualitative exploration.

Pre-exposure prophylaxis (PrEP) adherence remains a challenge among young men who have sex with men (MSM). We developed and tested a smartphone application ("app"), "DOT Diary", which combines automated directly observed therapy (DOT) with information about PrEP protection levels, pill-taking reminders, a sexual behavior diary, and a PrEP dosing calendar. To contextualize trial results, we qualitatively explored participants' app experiences.

Family influences on oral PrEP use among adolescent girls and young women in Kenya and South Africa.

Introduction: Effective use of oral HIV pre-exposure prophylaxis (PrEP) has been lower among African adolescent girls and young women (AGYW) than among older women, young men who have sex with men, and serodiscordant heterosexual couples in the region. Efforts to build PrEP support have centered around peers and male partners, but the family may also play an important role. This qualitative study aimed to describe family influence on PrEP use among AGYW in in three African cities.

Women's motivations for participating in the dapivirine vaginal ring open label extension study.

Open-Label Extension (OLE) studies are important in the drug development process and are used to further support the licensing applications and regulatory approvals of products. We aimed to understand why women chose to join the HOPE OLE study - where women were offered the dapivirine vaginal ring after two pivotal trials were completed - through data collected from individual in-depth interviews. Ten women at each of the six HOPE research sites in Lilongwe, Malawi; Durban (2 sites) and Johannesburg, South Africa; Kampala, Uganda; and Chitungwiza, Zimbabwe, were enrolled ( = 60).

Male Partner Opinions of the Dapivirine Vaginal Ring Used During an Open-Label Extension HIV Prevention Trial in KwaZulu-Natal, South Africa.

Background: The dapivirine vaginal ring ("the ring") reduced HIV acquisition by about 35% in phase III trials, with modeling from open-label extension trials estimating 50% HIV protection with consistent use. The ring may be used without male partner knowledge. The Assessment of ASPIRE and HOPE Adherence (AHA) substudy aimed to understand the impact of sociocontextual issues on ring adherence.

Qualitative Analysis Using Social Maps to Explore Young Women's Experiences With Social Support of their Oral PrEP Use in Kenya and South Africa.

Daily oral pre-exposure prophylaxis (PrEP) adherence is challenging. We explored African adolescent girls and young women's (AGYW) perceptions of the social influencers of their PrEP use and the social influencers' PrEP knowledge and support (six focus group discussions; 33 South African and Kenyan AGYW) in the Prevention Options for Women Evaluation Research demonstration project. Participants completed a social mapping exercise indicating strength and direction of influence of members in their social networks.

Provider-client rapport in pre-exposure prophylaxis delivery: a qualitative analysis of provider and client experiences of an implementation science project in Kenya.

Daily oral pre-exposure prophylaxis (PrEP) is being incorporated into services frequented by adolescent girls and young women (AGYW) in sub-Saharan Africa who are at a significant risk of HIV. In non-PrEP studies, positive provider-client rapport has been shown to improve patient decision-making and use of medication in clinical care. We examined AGYW and healthcare provider (HCP) perspectives on the value of and strategies for building positive provider-client rapport.

Women's experience receiving drug feedback and adherence counseling in MTN-025/HOPE - an HIV Prevention open-label trial of the Dapivirine Vaginal Ring.

In the Phase IIIB MTN-025/HOPE open label extension trial, participants were offered the dapivirine vaginal ring as HIV prophylaxis, and those who accepted the ring received semi real-time individual adherence feedback, based on residual drug level (RDL) from returned rings, during Motivational Interviewing-based counseling. Counseling messages, based on the best knowledge at the time, framed RDL results in terms of ring use and HIV protection, from no use /no protection (0 RDL) to high use /high protection (3 RDL). At six HOPE sites, in-depth-Interviews (IDIs) about RDL were conducted with 64 participants who had received at least one RDL result.

Does the Ring Work? Perceptions and Understanding of the Efficacy of a Dapivirine Vaginal Ring for HIV Prevention Amongst Women in a Placebo-Controlled Trial.

As demonstrated by the Phase III clinical trial, MTN-020/ASPIRE, the monthly dapivirine vaginal ring is well tolerated and reduces the risk of HIV-1 as a woman-initiated prevention option. This analysis uses data from the follow-on MTN-032/Assessment of ASPIRE and HOPE Adherence (AHA) qualitative study to understand how perceptions (or misperceptions) of ring efficacy may have influenced behavior during ASPIRE, and affected intention to use the ring in future ring projects, specifically HOPE, the planned open-label extension study. Single in-depth interviews (n = 98) and 12 focus group discussions (n = 89) were conducted with women at seven sites in Malawi, South Africa, Uganda and Zimbabwe.

Adolescent girls and young women's PrEP-user journey during an implementation science study in South Africa and Kenya.

Successful scale-up of PrEP for HIV prevention in African adolescent girls and young women (AGYW) requires integration of PrEP into young women's everyday lives. We conducted interviews and focus group discussions with 137 AGYW PrEP users aged 16-25 from South Africa and Kenya. Individual and relational enablers and disablers were explored at key moments during their PrEP-user journey from awareness, initiation and early use through persistence, including PrEP pauses, restarts, and discontinuation.

Using Emoji Stickers to Understand End-User Opinions of the Dapivirine Vaginal Ring for HIV Prevention.

Globally, HIV affects women disproportionally to men, particularly in sub-Saharan Africa. While the monthly dapivirine vaginal ring (VR) is a promising female-initiated HIV prevention method, it is important to understand how well the ring is liked. With former participants of HOPE, an open-label extension trial of the ring, we used emoji stickers and a worksheet to explore female end-user's acceptability of and opinions about the VR.

Impact of Women's Home Environment on Use of the Dapivirine Vaginal Ring for HIV Prevention in Sub-Saharan Africa.

The monthly dapivirine vaginal ring has proven efficacious in reducing HIV incidence in two Phase 3 clinical trials. When considering the potential future availability of the ring to the public, key questions remain about the feasibility of integrating the ring as an HIV prevention intervention into women's lives. We conducted qualitative mapping interviews (n = 66) among women enrolled in MTN-025/HOPE, an open-label trial conducted in Malawi, South Africa, Uganda and Zimbabwe, to examine how home environments influenced use of the dapivirine vaginal ring.

Men's Sexual Experiences with the Dapivirine Vaginal Ring in Malawi, South Africa, Uganda and Zimbabwe.

The dapivirine vaginal ring has been well-tolerated and shown to prevent HIV in clinical trials. The ring is female initiated, yet endorsement for use is sought from male partners in many relationships. In clinical studies, participants have expressed worries about men detecting rings during vaginal sex, which introduces concerns about product use disclosure, sexual pleasure, penile harm, inter-partner dynamics, and ring removals.

Qualitative Perceptions of Dapivirine VR Adherence and Drug Level Feedback Following an Open-Label Extension Trial.

Background: There continues to be a need for HIV prevention options that women can initiate and use autonomously. The dapivirine vaginal ring (VR) has been shown to have a favorable safety profile and reduce the risk of HIV-1 acquisition. We report on women's experiences with VR adherence during the MTN-025/HIV Open-label Prevention Extension (HOPE) study and responses to Residual Drug Level (RDL) results.

Changes in Identification of Possible Pain Coping Strategies by People with Osteoarthritis who Complete Web-based Pain Coping Skills Training.

Background: We previously demonstrated that automated, Web-based pain coping skills training (PCST) can reduce osteoarthritis pain. The present secondary analyses examined whether this program also changed coping strategies participants identified for use in hypothetical pain-related situations.

Method: People with hip/knee osteoarthritis (n = 107) were randomized to Web-based PCST or standard care control.

The Power of the Shared Experience: MTN-020/ASPIRE Trial Participants' Descriptions of Peer Influence on Acceptability of and Adherence to the Dapivirine Vaginal Ring for HIV Prevention.

Women are disproportionately at risk of acquiring HIV in East and Southern Africa, despite global declines in incidence. Female-initiated HIV prevention methods, like the dapivirine vaginal ring, are needed to end the HIV epidemic. In-depth interviews and focus groups retrospectively explored peer influence on acceptability of and adherence to the ring during the ASPIRE trial, a phase III placebo-controlled trial.

Hygiene, Blood Flow, and Vaginal Overload: Why Women Removed an HIV Prevention Vaginal Ring During Menstruation in Malawi, South Africa, Uganda and Zimbabwe.

We assessed the interference between vaginal ring use and menses among women who participated in the qualitative component of the MTN-020/ASPIRE vaginal ring trial in Malawi, South Africa, Uganda and Zimbabwe (N = 214). A common reason for imperfect ring adherence and premature removal of the vaginal ring cited by participants related to vaginal bleeding or menses. Whereas self-reporting via survey questions suggested that the majority (60%) of women did not mind wearing the ring while menstruating, and did not remove it (91%) during menses, in the qualitative interviews women frequently described removing the ring during menses.

Understanding women's motivations to participate in MTN-003/VOICE, a phase 2b HIV prevention trial with low adherence.

Background: In biomedical prevention trials, correct and consistent use of the investigational product is crucial to determine efficacy. Product adherence in VOICE, a phase 2B randomized trial of a vaginal gel and oral tablets for HIV prevention, was low (~ 34%), yet self-reported adherence and retention was high (> 90%). This analysis from VOICE-D, a post-trial qualitative ancillary study, explores motivations to participate in VOICE, and possible sources of misalignment between the stated priorities of the trial and the participants.

Reasons for nonadherence to the dapivirine vaginal ring: narrative explanations of objective drug-level results.

Objective(s): MTN-020/ASPIRE trial and IPM-027/Ring Study recently proved the dapivirine vaginal ring was safe and effective with consistent use. To optimize the ring's impact, the barriers and facilitators to ring adherence must be understood and addressed.

Methods: Former ASPIRE participants were stratified by age group (18-21; 22-45) and randomly selected at seven sites in Malawi, South Africa, Uganda and Zimbabwe, 12-17 months after trial exit.