The Role of Families in Adolescent and Young Adults' PrEP Use.

While pre-exposure prophylaxis (PrEP) is a key HIV prevention tool for adolescents and young adults (AYAs), its initiation and sustained use is shaped by AYAs' unique social contexts, including family. We explored the role of families in AYAs' PrEP use through qualitative in-depth interview (IDI) data from iPrevent, an end-user study designed to identify factors that could optimize PrEP adherence among South African youth (18-24 years old). These data were collected using a semi structured guide and were analysed using an inductive approach. Several themes describing family influence on AYAs' PrEP use emerged including family support; family attitude towards PrEP; and the family's ability to obviate PrEP disclosure challenges. In addition, dimensions of family closeness, categorized as 'close', 'in-between' and 'loose-knit,' appeared important in contextualizing family influence on AYAs' PrEP use. We found that family remains a proximal and fundamental social system in which AYA are socialized and greater family engagement could aid PrEP implementation in this priority population.

iPrevent: Engaging youth as long-acting HIV prevention product co-researchers in Cape Town, South Africa.

South African youth are one of the highest risk groups, globally, for HIV acquisition. Identifying prevention methods that will be acceptable and used consistently is an urgent priority. Engaging youth as co-designers is a targeted strategy to achieve the goal of developing prevention products that meet youth's needs. The iPrevent study engaged male and female youth, aged 18-24 years, in Cape Town, South Africa, to co-design critical aspects of the research project aimed at understanding youth preferences for long-acting pre-exposure prophylaxis (PrEP). An established advisory board of young men who have sex with men, women who have sex with men and men-who-have-sex-with-men, as well as a purposively selected youth cohort were involved in film-making, survey design and interpretation of study results. Convening youth as co-designers had several impacts on iPrevent's approach and outputs. Youth input informed the use of local actors in the study's educational video, creating a "real-world" community setting that meaningfully situated the content. Their participation led to the successful development of survey language and images to explain scientific concepts in terms that would resonate (e.g. chili peppers to express product-associated pain). Lastly, their insight reviewing results led to clarifications around misinterpretations of risk perception and confirmed youth's desires for products that fit into their goals around family, future happiness and education. The engagement of youth through creative, interactive activities contributed to adaptations of the study design, research implementation and understanding of results. This was important for connecting with young end-users and translating study findings for product developers in a way that reflected the context of their lives.

An individually randomized controlled trial of a mother-daughter HIV/STI prevention program for adolescent girls and young women in South Africa: IMARA-SA study protocol.

BACKGROUND: South Africa has the world's largest HIV epidemic, but South African adolescent girls and young women (AGYW) acquire HIV at twice the rate of and seroconvert on average 5-7 years earlier than their male peers. Female caregivers (FC) are an untapped resource for HIV/STI prevention in South Africa and offer a novel opportunity to strengthen AGYW prevention efforts. This study will evaluate the effectiveness and cost-effectiveness of an evidence-based mother-daughter HIV/STI prevention program tested in the United States and adapted for South Africa, Informed Motivated Aware and Responsible Adolescents and Adults (IMARA), to decrease STI incident infections and increase HIV testing and counseling (HTC) and PrEP uptake in AGYW. METHODS: This is a 2-arm individually randomized controlled trial comparing IMARA to a family-based control program matched in time and intensity with 525 15-19-year-old Black South African AGYW and their FC-dyads in Cape Town's informal communities. AGYW will complete baseline, 6-, and 12-month assessments. Following randomization, AGYW-FC dyads will participate in a 2-day group workshop (total 10 h) that includes joint and separate mother and daughter activities. Primary outcomes are AGYW STI incidence, HTC uptake, and PrEP uptake at 6 months. Secondary outcomes are AGYW STI incidence, HTC uptake, and PrEP uptake at 12 months, sexual behavior (e.g., condom use, number of partners), HIV incidence, and ART/PrEP adherence and intervention cost-effectiveness. AGYW who test positive for a STI will receive free treatment at the study site. HIV positive participants will be referred to ART clinics. DISCUSSION: Primary prevention remains the most viable strategy to stem new STI and HIV transmissions. HIV and STI disparities go beyond individual level factors, and prevention packages that include supportive relationships (e.g., FC) may produce greater reductions in HIV-risk, improve HTC and PrEP uptake, and increase linkage, retention, and adherence to care. Reducing new HIV and STI infections among South African AGYW is global public health priority. TRIAL REGISTRATION: ClinicalTrials.gov Number NCT04758390 , accepted 02/16/2021.

Long-Acting Injection and Implant Preferences and Trade-Offs for HIV Prevention Among South African Male Youth.

BACKGROUND: Long-acting pre-exposure prophylaxis (LA-PrEP) formulated as implants and injections are promising prevention method strategies offering simplicity, discretion, and long dose duration. Men are important end users of LA-PrEP, and early assessment of their preferences could enhance downstream male engagement in HIV prevention. METHODS: A discrete-choice experiment survey was conducted with 406 men, aged 18-24, in Cape Town, South Africa, to assess preferences for 5 LA-PrEP attributes with 2-4 pictorially-depicted levels: delivery form, duration, insertion location, soreness, and delivery facility. Latent class analysis was used to explore heterogeneity of preferences and estimate preference shares. RESULTS: The median age was 21 (interquartile range 19-22), and 47% were men who have sex with men. Duration was the most important product attribute. Latent class analysis identified 3 classes: "duration-dominant decision makers" (46%) were the largest class, defined by significant preference for a longer duration product. "Comprehensive decision makers" (36%) had preferences shaped equally by multiple attributes and preferred implants. "Injection-dominant decision makers" (18%) had strong preference for injections (vs. implant) and were significantly more likely to be men who have sex with men. When estimating shares for a 2-month injection in the buttocks with mild soreness (HPTN regimen) vs. a 6-month implant (to arm) with moderate soreness (current target), 95% of "injection-dominant decision makers" would choose injections, whereas 79% and 63% of "duration-dominant decision makers" and "comprehensive decision makers" would choose implant. CONCLUSIONS: Young South African men indicated acceptability for LA-PrEP. Preferences were shaped mainly by duration, suggesting a sizeable market for implants, and underscoring the importance of product choice. Further research into men's acceptability of LA PrEP strategies to achieve engagement in these HIV prevention tools constitutes a priority.

Preferences for long-acting Pre-Exposure Prophylaxis (PrEP) for HIV prevention among South African youth: results of a discrete choice experiment.

INTRODUCTION: Existing biomedical HIV prevention options, though highly effective, present substantial adherence challenges. End-user input on early-stage design of new HIV prevention approaches is critical to yielding products that achieve high uptake and adherence. The iPrevent Study examined youths' preferences for key attributes of long-acting Pre-Exposure Prophylaxis (PrEP), with a focus on characteristics pertinent to product delivery alongside key modifiable product attributes. METHODS: A discrete choice experiment was conducted with female and male youth aged 18 to 24 in two high-density communities in Cape Town, South Africa during the period July 2017 to January 2019. Sexually active, PrEP-naïve youth were recruited using population-based sampling; targeted sampling was used to enrol men who have sex with men (MSM). In a series of nine questions, participants were asked to choose between two hypothetical products composed of five attributes (form, dosing frequency, access, pain, insertion site). We used a random-parameters logit model to estimate preference weights and trade-offs among product alternatives. We examined differences across three subgroups: females, men who have sex with only women (MSW) and MSM. RESULTS: A total of 807 participants (401 female) were enrolled with a median age of 21 years. Males included 190 MSM. Most youth had tested for HIV (95%) and reported being HIV-negative (91%). Across all groups, duration of effectiveness was the most important attribute, with strong preference for less frequent dosing. Injections were favoured over implants, though these preferences were strongest for females and MSM. Females preferred a product offered at a health clinic and disliked pharmacy access; all groups preferred the arm as the insertion site. Youth were willing to trade their preferred product form for longer duration. CONCLUSIONS: Youth indicated strong preferences for longer duration products. Each attribute nonetheless influenced preferences, offering insight into trade-offs that inform long-acting PrEP development.

The Invisible Product: Preferences for Sustained-Release, Long-Acting Pre-exposure Prophylaxis to HIV Among South African Youth.

BACKGROUND: Long-acting injectable and implantable approaches aim to overcome some of the documented challenges with uptake and adherence to current HIV prevention methods. Youth are a key end-user population for these methods. We used qualitative methods to examine product attributes and preferences for current and future long-acting HIV prevention approaches. METHODS: Ninety-five South African youth aged 18-24 years, of whom 62 were female and 33 male, completed 50 interviews and 6 focus groups. We purposively selected for previous product experience, including oral pre-exposure prophylaxis, injectable pre-exposure prophylaxis, or the vaginal ring, to ensure participants' opinions were rooted in actual experience. RESULTS: Irrespective of previous method-use experience, gender, or sexual orientation, the majority expressed a preference for prevention methods formulated as injectables or implants. Several mentioned that their top priority in any product was efficacy, and for some, this overrode other concerns; for example, even if they feared pain, an implant or an injectable would be used if fully protective. Although efficacy was a top priority, there was also a clear desire across all subgroups for a product that would not interfere with sex, would stay in the system to provide protection, and that caused minimal burden, or was not apparent to others, and these characteristics were most salient for long-acting methods. CONCLUSIONS: Narrative explanations for preferences converged thematically around different dimensions of "invisibility" including invisibility to oneself, one's partner and household members, and community members. End-user preferences can be used to inform product development of long-acting HIV prevention approaches formulated as injections or implants to optimize adherence and impact.

Perspectives of South African youth in the development of an implant for HIV prevention.

INTRODUCTION: Implants are a new dosage form in development for HIV pre-exposure prophylaxis (PrEP) with potential for high adherence given that they are provider-administered and are intended for long-acting protection. Integrating end-user preference into early stage product development may further overcome challenges with future product uptake and adherence. Hence, we sought to optimize the design of a PrEP implant in early-stage development by gathering opinions about implant attributes from potential end-users in South Africa. METHODS: We conducted 14 focus group discussions (FGDs) with young women and men aged 18 to 24 in Cape Town and Soshanguve, South Africa, inviting participants into discussion as co-designers. FGDs were homogenous by gender and previous implant experience. During FGDs, we showed prototype devices and followed a semi-structured guide with questions on history of contraceptive implant use, preferences for physical characteristics of an implant, implant biodegradability, insertion process, participant-driven ideas for implant design, and social adoption considerations. FGDs were facilitated in English, isiXhosa, Tswana, isiZulu, or Tsonga, audio-recorded, transcribed into English, and qualitatively coded and analysed. RESULTS: In this qualitative sample of 105 youth (68 women and 37 men), 58 participants were from Soshanguve and 47 from Cape Town, and 23% had previously used contraceptive implants. Participants expressed preferences for several implant design features; specifically, longer duration (≥6 months) was more important to most participants than the size or number of devices implanted. A majority preferred a flexible versus stiff implant to minimize palpability, thereby increasing discreetness and comfort. Nearly all participants favoured a biodegradable implant to avoid removal and thus reduce clinic visits. Concerns about the implant centred on its possible side effects and the "plastic" look of the prototype displayed for demonstration. CONCLUSIONS: This study offers preliminary insights into an implant for HIV prevention that provides long-lasting protection may be well received among young South Africans. Additionally, flexibility, discreetness, and biodegradability may increase acceptability of the implant. Such end-user feedback is being incorporated into current implant designs in the hope of creating an effective long-acting PrEP product that is likely to achieve high uptake and adherence in target populations.