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Background: Female-initiated prevention products could reduce HIV infection rates in contexts with pronounced gender inequality like South Africa, but uptake and adherence remain low when available. Insights into the behavior of target consumers are needed to effectively promote these products; however, perceptions of stigma may discourage honest reporting. Focus of the Article: To address this need, we examined differences among the consumer journeys of six segments of South African adolescent girls and young women (AGYW), who vary on sexual health beliefs, sexual experience, and self-enhancement, when buying hygiene products. Research Question: We hypothesized that segments would differ in what motivated their purchases and in engagement with different touchpoints, reflecting a need for targeted outreach strategies. Methods: 1,500 low-income, Black South African AGYW (14–25 years of age) were surveyed face-to-face in their homes about their consumer journeys when purchasing deodorant and sanitary products, with the aim of extending the insights obtained to HIV prevention. Results: We found notable similarities across segments but also several important differences underscoring the potential for tailored marketing of HIV prevention products. Among some of the segments, differences were found in prepurchase mindsets and touchpoints, retail and brand drivers, and postpurchase feelings. Recommendations for Research or Practice: These findings highlight the need for tailored outreach among AGYW and may inform the design of effective, personalized marketing strategies that enhance the appeal of HIV prevention products. Limitations: To circumvent potential stigma associated with HIV, survey questions were anchored on personal hygiene products. While this may encourage greater honesty, findings may not fully generalize to HIV prevention products.

AbstractIntroductionWomen in sub‐Saharan Africa spend a substantial portion of their reproductive lives pregnant and/or breastfeeding (P/BF), yet they have limited options to prevent HIV during these maternal stages. In preparation for phase 3b prevention trials in P/BF women, we explored attitudes about using a vaginal ring or oral pills for pre‐exposure prophylaxis (PrEP), perceptions of HIV risk during P/BF and key influences on future PrEP use.MethodsIn 2018, we conducted 16 single‐sex focus group discussions (FGDs) with community‐ and clinic‐recruited HIV‐uninfected women, currently or recently P/BF, aged 18 to 40, and men with (currently or recently) P/BF partners, aged 18+. Participants completed a behavioural questionnaire, viewed an educational video and handled prototype placebo products. FGDs were conducted in local languages and transcribed, coded and analysed, using a socio‐ecological framework, for key influences on willingness to use products, HIV risk perceptions and opinions on product attributes.ResultsOf the 128 participants (65 women, 63 men) 75% lived with their partner and 84% had a child. Women reported the most important influencers when P/BF were partners, and all stated that health decisions when P/BF are typically made jointly (e.g. medication use; ante/postnatal and baby care). There was consensus that P/BF women are at high risk for HIV, primarily because of their partner's infidelities, and new prevention options were welcomed. Participants valued multiple options and stated that woman's personal preference would be key to product choice. Anticipated concerns about products included risk of miscarriage, impact on infant development, complications during delivery and adequate production or taste of breastmilk. Specific perceived disadvantages emerged for the ring (e.g. vaginal discomfort, difficulty inserting/removing) and for pills (e.g. nausea/vomiting) that may be exacerbated during pregnancy. Health care providers' (HCPs) knowledge and approval of product use during P/BF was needed to mitigate anticipated fears.ConclusionsParticipants perceived pregnancy and breastfeeding as high HIV risk periods and valued new prevention options. HIV protection of the mother‐child dyad, safety of the baby, and ultimately, health of the family were paramount. Endorsement by HCPs and support from partners were key to future product acceptance. Participants recommended involving partners and HCPs in sensitization efforts for future trials.

AbstractIntroductionYoung women in sub‐Saharan Africa account for two‐thirds of all new HIV infections and face high rates of unintended pregnancy. Multipurpose prevention technologies (MPTs) are promising products under development that are designed to simultaneously prevent HIV and unintended pregnancy. Since MPTs will be used in the context of sexual relationships, ensuring acceptability and use requires understanding the role of male partners in MPT use decision‐making.MethodsThis paper draws on qualitative data from 39 couples enrolled in the Microbicide Trials Network (MTN) 045 study, conducted in 2019–2020. Partners completed a discrete choice experiment (DCE), first separately and then jointly, to measure preferences for future MPT attributes and then completed a qualitative interview. We also draw on quantitative data from interviewer observation about who dominated the decision‐making process during the joint DCE. Content analysis was used to examine (1) how couples made decisions on existing non‐MPT HIV and pregnancy prevention products; (2) how couples made decisions on future ideal‐MPT product during the DCE; and (3) how these decision‐making processes varied by decision‐making dominance (10 male, 10 female and 19 equal) and interview type (19 joint and 20 separate).ResultsExisting non‐MPT product decisions focused on trust between partners and product attributes, while future ideal‐MPT product decisions exclusively focused on product attributes. Across existing and future products, preferences for product attributes varied by gender. Male partners were most concerned with limiting side effects impacting sexual pleasure, female partners were most concerned with limiting side effects causing physical symptoms and both were concerned with the return to fertility. Across all dominance and interview types, couples reported making decisions together and female partners were often able to negotiate with male partners for their preferred product or set of product attributes.ConclusionsResearch activities in this study provided an opportunity for couples to openly present their product attribute preferences to their partner, learn about their partner's attribute preferences, negotiate for their ideal set of attributes and ultimately choose attributes that benefited the couple without disempowering the female partner. Future research should focus on the utility of couple‐based decision‐making aids or similar tools for facilitating joint MPT decision‐making.

IntroductionVaginal tenofovir (TFV) 1% gel may reduce incident HIV‐1 and herpes simplex virus 2 infection. Pregnancy may increase risk of HIV acquisition, and incident HIV in pregnancy potentiates perinatal HIV transmission. Our objective was to investigate the safety and pharmacokinetics of seven days of TFV 1% vaginal gel in term and near‐term pregnancy.MethodsNinety‐eight healthy pregnant women, stratified to a term cohort followed by a near‐term cohort, were enrolled into a 2:1 randomized, double‐blinded, placebo‐controlled trial. Women received TFV or placebo gel for seven consecutive days with pharmacokinetic sampling on days 0 and 6. Maternal and cord blood were collected at delivery. Primary end points included laboratory and genital adverse events, adverse pregnancy and neonatal outcomes, and maternal TFV levels.ResultsMost adverse events were grade 1 and none of the grade 3 or 4 adverse events were related to study product. There was no significant difference in safety end points between the two pregnancy cohorts (p=0.18); therefore, their data were combined. Primary safety end point rates were similar for mothers randomized to the TFV gel vs placebo arm (72.7 and 68.8%, p=0.81). The same was true for newborns in the TFV gel vs placebo arms (4.5% vs 6.3%, p=0.66). All women randomized to TFV had quantifiable serum levels within eight hours of dosing, with low overall median (interquartile range) day 0 and day 6 peak values (3.8 (2.0 to 7.0) and 5.8 (2.6 to 9.4) ng/mL, respectively).ConclusionsDaily TFV 1% vaginal gel use in term and near‐term pregnancy appears to be safe and produces low serum drug levels.

IntroductionIn the Microbicide Trial Network MTN‐003 (VOICE) study, a Phase IIB pre‐exposure prophylaxis trial of daily oral or vaginal tenofovir (TFV), product adherence was poor based on pharmacokinetic (PK) drug detection in a random subsample. Here, we sought to compare behavioural and PK measures of adherence and examined correlates of adherence misreporting.MethodsWe included participants with PK and behavioural data from VOICE random subsample. Behavioural assessments included face‐to‐face interviews (FTFI), audio computer‐assisted self‐interviewing (ACASI) and pharmacy‐returned product counts (PC). TFV concentrations <0.31 ng/mL in plasma (oral group) and <8.5 ng/swab in vaginal group were defined as "PK non‐adherent." Logistic regression models were fit to calculate the combined predictive ability of the behavioural measures as summarized by area under the curve (AUC). Baseline characteristics associated with over‐reporting daily product use relative to PK measures was assessed using a Generalized Linear Mixed Model.ResultsIn this random adherence cohort of VOICE participants assigned to active products, (N=472), PK non‐adherence was 69% in the oral group (N=314) and 65% in the vaginal group (N=158). Behaviourally, ≤10% of the cohort reported low/none use with any behavioural measure and accuracy was low (≤43%). None of the regression models had an AUC >0.65 for any single or combined behavioural measures. Significant (p<0.05) correlates of over‐reporting included being very worried about getting HIV and being unmarried for the oral group; whereas for the vaginal group, being somewhat worried about HIV was associated with lower risk of over‐reporting.ConclusionsPK measures indicated similarly low adherence for the oral and vaginal groups. No behavioural measure accurately predicted PK non‐adherence. Accurate real‐time measures to monitor product adherence are urgently needed.Trial registration: ClinicalTrials.gov identifier: NCT00705679

AbstractIntroductionEnd‐user perspectives are vital to the design of new biomedical HIV prevention products. Conjoint analysis can support the integration of end‐user perspectives by examining their preferences of potential pre‐exposure prophylaxis (PrEP) products. The Microbicides Trial Network (MTN) 035 protocol examined three placebo rectal dosage forms (insert, enema and suppository) that could deliver PrEP prior to receptive anal sex (RAS).MethodsBetween April 2019 and July 2020, we enrolled 217 HIV‐negative, cisgender men who have sex with men (MSM; n = 172; 79.3%) and transgender people (n = 47; 20.7%) ages 18–35 into a randomized cross‐over trial across Malawi, Peru, South Africa, Thailand and the United States. Participants used each product prior to RAS over 4‐week periods. Participants completed a conjoint experiment where they selected between random profiles using seven features (dosage form, timing of use before sex, side effects, duration of protection, effectiveness, frequency of use and need for a prescription).ResultsEffectiveness was the strongest determinant of choice (30.4%), followed by modality (18.0%), potential side effects (17.2%), frequency of use (10.8%), duration of protection (10.4%), timing of use before sex (7.4%) and need for a prescription (5.9%). Relative utility scores indicated that the most desirable combination of attributes was a product with 95% efficacy, used 30 minutes before sex, offering a 3‐ to 5‐day protection window, used weekly, having no side effects, in the form of an enema and available over‐the‐counter.ConclusionsChoice in next‐generation PrEP products is highly desired by MSM and transgender people, as no one‐size‐fits‐all approach satisfies all the preferences. MTN‐035 participants weighed product features differently, recognizing the need for diverse, behaviourally congruent biomedical options that fit the needs of intended end‐users.

AbstractIntroductionTenofovir‐based oral pre‐exposure prophylaxis is currently approved for HIV prevention; however, adherence in women has been low. A vaginal gel containing tenofovir (TFV) demonstrated partial protection to HIV but protection was not confirmed in additional studies. Vaginal rings offer user‐controlled long‐acting HIV prevention that could overcome adherence and protection challenges. TFV may also help prevent herpes simplex virus type 2 acquisition when delivered intravaginally. We evaluated the pharmacokinetics, safety, adherence and acceptability of a 90‐day TFV ring.MethodsBetween January and June 2019, Microbicide Trials Network (MTN)‐038 enrolled 49 HIV‐negative participants into a phase 1, randomized (2:1) trial comparing a 90‐day ring containing 1.4 grams (g) TFV to a placebo ring. TFV concentrations were quantified in plasma, cervicovaginal fluid (CVF), rectal fluid and cervical tissue, and TFV‐diphosphate (TFV‐DP) in cervical tissue. Used rings were analysed for residual TFV. Safety was assessed by adverse events (AEs); acceptability and adherence by self‐report.ResultsMean age was 29.5; 46 identified as cisgender‐female and three gender non‐conforming. There were no differences in the proportion of participants with grade ≥2 genitourinary AEs in the TFV versus placebo arms (p = 0.41); no grade ≥3 AEs were reported. Geometric mean TFV concentrations increased through day 34 in CVF/rectal fluid and day 59 in plasma, but declined across compartments by day 91. Geometric mean TFV‐DP tissue concentrations exceeded the 1000 fmol/mg target through day 56, but fell to 456 fmol/mg at day 91. Among 32 rings returned at the end of the study, 13 had no or low (<0.1 g) residual TFV. Residual TFV did not differ by socio‐demographics, sexual activity, Nugent Score or vaginal microbiota. Most participants reported being fully adherent to ring use: 85% and 81% in the TFV and placebo arms, respectively (p = 1.00). A majority of participants reported liking the ring (median 8 on a 10‐point Likert scale) and reported a high likelihood of using the ring in the future, if effective (median 9).ConclusionsThe 90‐day TFV ring was well‐tolerated, acceptable and exceeded target cervical tissue concentrations through day 56, but declined thereafter. Additional studies are needed to characterize the higher release from TFV rings in some participants and the optimal duration of use.

AbstractIntroductionVaginal rings are a promising approach to provide a woman‐centred, long‐acting HIV prevention strategy. Prior trials of a 25 mg dapivirine (DPV) ring have shown a favourable safety profile and approximately 30% risk reduction of HIV‐1 infection. Extended duration rings replaced every three months may encourage user adherence, improve health service efficiency and reduce cost overall. We evaluated safety, pharmacokinetics, adherence and acceptability of two three‐month rings with different DPV dosages, compared with the monthly DPV ring.MethodsFrom December 2017 to October 2018, MTN‐036/IPM‐047 enrolled 49 HIV‐negative participant in Birmingham, Alabama and San Francisco, California into a phase 1, randomized trial comparing two extended duration (three‐month) rings (100 or 200 mg DPV) to a monthly 25 mg DPV ring, each used over 13 weeks, with follow‐up completed in January 2019. Safety was assessed by recording adverse events (AEs). DPV concentrations were quantified in plasma, cervicovaginal fluid (CVF) and cervical tissue, at nominal timepoints. Geometric mean ratios (GMRs) relative to the comparator ring were estimated from a regression model.ResultsThere were no differences in the proportion of participants with grade ≥2 genitourinary AEs or grade ≥3 AEs in the extended duration versus monthly ring arms (p = 1.0). Plasma and CVF DPV concentrations were higher in the extended duration rings compared to the monthly ring. Plasma GMRs were 1.31 to 1.85 and 1.41 to 1.86 and CVF GMRs were 1.45 to 2.87 and 1.74 to 2.60 for the 100 and 200 mg ring respectively. Cervical tissue concentrations were consistently higher in the 200 mg ring (GMRs 2.36 to 3.97). The majority of participants (82%) were fully adherent (ring inserted at all times, with no product discontinuations/outages) with no differences between the monthly versus three‐month rings. Most participants found the ring acceptable (median = 8 on 10‐point Likert scale), with a greater proportion of participants reporting high acceptability (9 or 10) in the 25 mg arm (73%) compared with the 100 mg (25%) and 200 mg (44%) arms (p = 0.01 and p = 0.15 respectively).ConclusionsThe extended duration DPV rings were well‐tolerated and achieved higher DPV concentrations compared with the monthly DPV ring. These findings support further evaluation of three‐month DPV rings for HIV prevention.