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. PrEP uptake was facilitated when offered as part of an integrated sexual reproductive health service, but hampered by low awareness, stigma and misconceptions about PrEP in the community. Daily pill-taking was challenging for AGYW due to individual, relational and structural factors and PrEP interruptions (intended or unintended) were described as part of AGYW's PrEP-user journey. Disclosure, social support, adolescent-friendly health counseling, and convenient access to PrEP were reported as key enablers for PrEP persistence.
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. This subanalysis provides insight into disclosure and male partner influence on ring acceptability.
Data were collected using 4 focus group discussions with 18 male partners of phase III trial participants at 2 sites in KwaZulu-Natal, South Africa. Qualitative data were coded, summarized by urban vs. rural location, and analyzed thematically.
Male partners aged 23-49 years wanted to be informed about the ring use to maintain the trust in their relationships. Their initial response to the ring was characterized by fear due to perceived impact of the ring on their female partner's reproductive system, their penile safety, and that the ring would encourage women to engage in unprotected sex and infidelity. Over time and with information and experience with having a partner who had used the vaginal ring, this fear transformed to support for women to have their own HIV prevention option.
Male partners supported the ring as an HIV prevention method for women but wanted to be informed about its use. Engaging male partners on female-initiated HIV prevention methods and increased education among rural men may contribute to improved partner support and facilitate women's consistent use.
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. POWER (Prevention Options for Women Evaluation Research) was a PrEP demonstration project among 2550 AGYW (16-25 years old) in Johannesburg and Cape Town, South Africa and Kisumu, Kenya conducted from 2017 to 2020. In-depth interviews and focus group discussions were conducted with 136 AGYW participants to explore their PrEP views and experiences, including awareness and interest in PrEP; barriers and facilitators to uptake and use; the influence of family, peers, intimate partners, and community; and the key types of support for their PrEP use. Transcripts were coded and analysed thematically. The decision to initiate PrEP was associated with fear and anxiety linked to anticipated stigma from family members, and with family's lived HIV experience. Family disclosure, especially to mothers, was important to participants, as most lived with their families and considered it essential for them to obtain their mother's approval to use PrEP. Most family members, particularly mothers, provided instrumental, emotional, informational and appraisal support to participants using PrEP, including reminders, encouragement, and problem-solving. Participants reported that family members with insufficient information about PrEP safety and efficacy and who voiced concerns were a substantial barrier to their use. However, they often became supportive after receiving more PrEP information. Families, particularly mothers, can play an important role in supporting PrEP use. PrEP programmes should leverage family support to help with PrEP persistence by providing basic information to families about PrEP safety and efficacy. AGYW using PrEP should be encouraged to selectively disclose PrEP use to build support and counseled on how to disclose and address family concerns.
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. This study reports African men’s firsthand sexual experiences with the ring. Qualitative data were captured through 11 focus group discussions and one in-depth interview with 54 male partners of ring-users at six research sites in Malawi, South Africa, Uganda and Zimbabwe. Following a semi-structured guide, and using demonstration rings, vulva and penis models, men were asked to discuss the ring’s impact on sex and views on male engagement and ring use. Interviews were facilitated by local male social scientists, audio-recorded, translated into English, and analyzed thematically. 22 (41%) of the male partners reported feeling the ring during sex, often attributed to perceived incorrect insertion. Many men described the ring as “scratching” the tip of their penises, and sensations of “prodding” something that “blocked” the vagina and prohibited “full entry”. In most cases, feelings dissipated with time or when sexual fluids increased. Less common descriptions included perceiving the vaginal texture, wetness and size as different, which increased pleasure for some, and decreased for others. Over half (59%) never noticed the ring; some attempting and failing to feel it during intercourse. A majority of men reported that the ring did not lead to changes in sexual positions, feelings, frequency or experience of sex, although some were initially afraid that the ring was a “magic snake” or “potion”. Male partners expressed strong opinions that ring use was a shared prevention responsibility that men should be engaged in, especially for maintaining trust and open communication in relationships. The ring was noticed by many male partners, particularly during women’s initial stages of ring use, although this led to few sexual problems or changes. Nevertheless, results suggest that risk of ring discovery should be discussed with women to mitigate any potential negative reactions or social harm. Strategies to increase male partner engagement will enhance support of this prevention method for women.
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. Results were analyzed using an inductive analytic approach. Study participants (peers) of all ages and adherence groups developed important interpersonal connections and reported being more open and honest with each other than with external peers or study staff. Study peers who knew each other prior to joining appeared to have a stronger influence on each other’s adherence than peers who met in the study. External peers provided primarily negative input about the ring and study, which sometimes led to ring removals. Peers’ influence on each other’s behavior in both prosocial and detrimental manners could have repercussions on adherence to a biomedical intervention, and consequently, individual disease risk and clinical trial outcomes. Future ring demonstration and implementation studies could use peer networks to intentionally influence uptake and adherence to the ring.
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 ringʼs 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. Using in-depth interviews or focus group discussions, ring use barriers were explored using structured guides and visual tools including individual-level depictions of dapivirine levels detected in plasma and returned rings.
RESULTS:A total of 187 were enrolled; 37% were 18–21 years when they began ASPIRE. Most (75%) had drug-level results, suggesting inconsistent ring use throughout ASPIRE. Participants viewed themselves as adherent, while simultaneously describing regular instances and reasons for ring removal (e.g. for sex or menses). Less adherent women reported fears that partners would oppose the ring or feel it during sex. High adherers expressed altruistic motivations for ring use. Women of all ages attributed young womenʼs nonadherence to their tendency to be less ‘serious’ about the future, HIV prevention and the study; motivated predominantly by benefits; more fearful of fertility-related consequences; and to having less relationship control.
CONCLUSION:When presented with objective adherence data, participants provided reasons for intermittent ring use, while simultaneously portraying themselves as consistent ring users. Further research is needed to understand how women could use the ring in a way that fits into the context of their relationships and their lives while still conferring adequate HIV prophylaxis.
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.
VOICE-D enrolled 171 former VOICE participants to investigate, among other things, reasons for joining and remaining in the trial. Local language in-depth interviews and focus groups were transcribed and translated into English and coded and analyzed using NVivo. Data on motivation to join obtained from a VOICE termination visit survey of 106 participants were also analyzed to corroborate the VOICE-D findings.
Participants primarily participated for personal health benefits (e.g. free healthcare and HIV testing) and reported remaining enrolled from a sense of commitment to the trial. Altruistic motivations were the most commonly stated motivation on the termination visit survey; qualitatively, many of those stating altruistic reasons also desired personal health benefits. Joining for financial reimbursement was not commonly mentioned. Social networks influenced recruitment and spread therapeutic misconception.
Women's participation for personal health benefits highlighted their desire to monitor their HIV risk and overall health. Helping participants view use of investigational products as improving social capital and reminding participants of their study responsibilities may improve trial outcomes. Understanding the reasons for participating in studies will help to ensure alignment between priorities of researchers and participants.
NCT02358616 ; Posted February 9, 2015, retrospectively registered.
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. At baseline and post-intervention, they reported their pain severity and impairment, then completed a task in which they described how they would cope with pain in four hypothetical pain-related situations, also reporting their perceived risk for pain and self-efficacy for managing it. We coded the generated coping strategies into counts of adaptive behavioral, maladaptive behavioral, adaptive cognitive, and discrete adaptive coping strategies (coping repertoire).
Results
Compared to the control arm, Web-based PCST decreased the number of maladaptive behavioral strategies generated (
p
= 0.002) while increasing the number of adaptive behavioral strategies generated (
p
= 0.006), likelihood of generating at least one adaptive cognitive strategy (
p
= 0.01), and the size of participants’ coping repertoire (
p
= 0.009). Several of these changes were associated with changes in pain outcomes (
p
s = 0.01 to 0.65). Web-based PCST also reduced perceived risk for pain in the situations (
p
= 0.03) and increased self-efficacy for avoiding pain in similar situations (
p
< 0.001).
Conclusion
Salutary changes found in this study appear to reflect intervention-concordant learning.
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. Eligibility included participation in the ASPIRE active arm, and ring use for ≥ 3 months or at least 1 month if seroconversion occurred. Interviews were audio-recorded, transcribed into English, coded in Dedoose and thematically analyzed. Demographic and behavioral questionnaire data were summarized in Stata. Most AHA participants perceived the ring to be effective, and described simply trusting it or having confidence in it because they, or other participants in risky situations, remained HIV-uninfected. Participants described ring efficacy after receiving ASPIRE results as a binary assessment: the ring worked or not. Many did not remember exact efficacy percentages because of lack of comprehension or memory but recalled key details about age differences. The majority expressed interest in future ring use. There is a need to investigate improved ways of explaining placebo-controlled trials and efficacy to women in Sub-Saharan Africa. Now that ring efficacy, is known, these benefits must be well communicated, and understood by end-users and key stakeholders. Engagement with end-users to construct effective messages and to develop tools to measure understanding of partial efficacy will be essential.
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. We aimed to understand these participants’ opinions about the VR, and how they had changed over time, particularly in the context of known efficacy of the dapivirine VR. Most participants easily understood the exercise and how to use the emoji stickers, with a few exceptions. For those who had trouble understanding how to use the emoji, interviewer support and encouragement helped them to understand and continue with the exercise. Emoji interpretation varied widely with participants using the same emoji to express divergent opinions. Using the emoji stickers, participants expressed mostly positive opinions of the vaginal ring for HIV prevention, with some lingering concerns about the product’s partial effectiveness. This paper contributes to the literature supporting the assertion that the dapivirine VR for HIV prevention is acceptable to women, and that acceptability increases with time and proper education. This analysis also provides evidence that emoji visual tools can enhance understanding of acceptability of an intervention when used in qualitative research.
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