Correlates of Adherence to Oral and Vaginal Pre-exposure Prophylaxis (PrEP) Among Adolescent Girls and Young Women (AGYW) Participating in the MTN-034/REACH Trial.

We evaluated correlates of adherence to PrEP, including daily oral tenofovir disoproxil fumarate in combination emtricitabine (oral FTC/TDF) and the monthly dapivirine ring (ring)among adolescent girls and young women (AGYW) in the MTN-034/REACH study. We enrolled 247 AGYW aged 16-21 years in South Africa, Uganda and Zimbabwe (ClinicalTrials.gov: NCT03074786). Participants were randomized to the order of oral FTC/TDF or ring use for 6 months each in a crossover period, followed by a 6-month choice period. We assessed potential adherence correlates-individual, interpersonal, community, study, and product-related factors-quarterly via self-report. We measured biomarkers of adherence monthly; high adherence was defined as > 4 mg dapivirine released from returned rings or intracellular tenofovir diphosphate levels ≥ 700 fmol/punch from dried blood spots (DBS). We tested associations between correlates and objective measures of high adherence using generalized estimating equations. High adherence to oral FTC/TDF was significantly associated with having an older primary partner (p = 0.04), not having exchanged sex in the past 3 months (p = 0.02), and rating oral FTC/TDF as highly acceptable (p = 0.003). High ring adherence was significantly associated with unstable housing (p = 0.01), disclosing ring use to a male family member (p = 0.01), and noting a social benefit from study participation (p = 0.03). All associations were moderate, corresponding to about 6%-10% difference in the proportion with high adherence. In our multinational study, correlates of adherence among African AGYW differed for oral FTC/TDF and the ring, highlighting the benefit of offering multiple PrEP options.

Organize and mobilize for implementation effectiveness to improve overdose education and naloxone distribution from syringe services programs: a randomized controlled trial.

BACKGROUND: The United States (US) continues to face decades-long increases in opioid overdose fatalities. As an opioid overdose reversal medication, naloxone can dramatically reduce opioid overdose mortality rates when distributed to people likely to experience or witness an opioid overdose and packaged with education on its use, known as overdose education and naloxone distribution (OEND). Syringe services programs (SSPs) are ideal venues for OEND with staff who are culturally competent in providing services for people who are at risk of experiencing or observing an opioid overdose. We carried out a randomized controlled trial of SSPs to understand the effectiveness of the organize and mobilize for implementation effectiveness (OMIE) approach at improving OEND implementation effectiveness within SSPs. METHODS: Using simple randomization, 105 SSPs were enrolled into the trial and assigned to one of two study arms - (1) dissemination of OEND best practice recommendations (Control SSPs) or the OMIE approach along with dissemination of the OEND best practice recommendations (i.e., OMIE SSPs). OMIE SSPs could participate in 60-min OMIE sessions once a month for up to 12 months. At 12-month post-baseline, 102 of 105 SSPs (97%) responded to the follow-up survey. RESULTS: The median number of sessions completed by OMIE SSPs was 10. Comparing OMIE SSPs to control SSPs, we observed significant increases in the number of participants receiving naloxone (incidence rate ratio: 2.15; 95% CI: 1.42, 3.25; p < 0.01) and the rate of naloxone doses distributed per SSP participant (adjusted incidence rate ratio: 1.97; 95% CI: 1.18, 3.30; p = 0.01). We observed no statistically significant difference in the number of adopted best practices between conditions (difference in means 0.2, 95% CI: - 0.7, 1.0; p = 0.68). We also observed a threshold effect where SSPs receiving a higher OMIE dose had greater effect sizes with regard to the number of people given naloxone and the number of naloxone doses distributed. CONCLUSIONS: In conclusion, the multifaceted OMIE approach was effective at increasing naloxone distribution from SSPs, despite substantial external shocks during the trial. These findings have major implications for addressing the overdose crisis, which has continued unabated for decades. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03924505 . Registered 19 April 2019.

Acceptability of the dapivirine vaginal ring for HIV-1 prevention among women reporting engagement in transactional sex.

We assessed if acceptability of the dapivirine vaginal ring for HIV prevention differed among the subgroup of women who reported engaging in transactional sex prior to enrollment in MTN-020/ASPIRE (phase III trial in Malawi, South Africa, Uganda, and Zimbabwe, 2012-2015; n = 2629). Transactional sex was defined as receipt of money, goods, gifts, drugs, or shelter in exchange for sex in the past year. Dimensions of acceptability included: ease of use and physical sensation in situ, impacts on sex, partner's opinion, and likelihood of future use. We used Poisson regression models with robust standard errors to compare risk of acceptability challenges by baseline history of transactional sex. At product discontinuation, women exchanging sex found the ring comfortable (90%), easy to insert (92%) and nearly all (96%) were likely to use the ring in the future. Women who had exchanged sex were more likely to report feeling the ring during sex (ARR 1.43, 95% CI: 1.09, 1.89; p = 0.01) and slightly more likely to mind wearing the ring during menses (ARR 1.22, 95% CI: 1.01, 1,46; p = 0.04) and during sex (ARR 1.22, 95% CI: 1.02, 1.45; p = 0.03). Messaging and counseling should include enhanced support for use during sex and menses to support optimal use.

Health risks associated with smoking versus injecting fentanyl among people who use drugs in California.

BACKGROUND: Given the attention, funding, and services that seek to reduce overdose mortality from fentanyl, it is important to understand whether a potential solution is for more people to switch from injecting to smoking fentanyl. As such, we set out to conduct a study to compare health and healthcare utilization outcomes associated with different modes of illicit fentanyl administration. METHODS: From January to February 2023, we recruited people who use drugs from 34 syringe services programs across California, USA (N=999) and surveyed their substance use, health outcomes, and healthcare utilization. We compared health risks among people who injected fentanyl (78% of whom also smoked) to people who solely smoked fentanyl (n=563). RESULTS: Of the 563 participants, forty-one percent injected fentanyl and 59% only smoked fentanyl. People who injected fentanyl were 40% more likely to have experienced a non-fatal overdose in the past 3 months (27% vs. 19%; aRR=1.40; 95% CI=1.03, 1.93) and 253% more likely to have had a skin and soft tissue infection in the past 3 months (39% vs. 15%; aRR=2.53; 95% CI=1.74, 3.67), compared to people who only smoked fentanyl. The average number of nights spent in the hospital was higher among people who injected fentanyl (average 1.2 nights vs. 0.7 nights; aIRR=1.78; 95% CI=1.02, 3.09; p=0.04).There were non-significant associations between mode of fentanyl administration and number of emergency department visits and probability of hospitalization. CONCLUSIONS: Findings suggested that people who injected fentanyl were at higher risk for overdose and skin and soft tissue infections than people who only smoked fentanyl. Distribution of safe smoking supplies may facilitate transitions from injecting to smoking fentanyl, thereby reducing health risks associated with fentanyl use.

Decreased Homelessness among Women Involved in the Criminal Legal System after a COVID-19 Housing Intervention.

The COVID-19 outbreak fueled unprecedented public health efforts to mitigate the spread of infection, including rapid provision of non-congregate housing to people experiencing homelessness. People on community supervision (criminal probation or parole) have high levels of homelessness due to housing discrimination, poverty and racism, and are among the groups most vulnerable to COVID-19. We examined housing status in a cohort of women with probation histories in Alameda County, CA before and after the COVID-19 outbreak (N=204). Before March 2020, 38% of women in the cohort reporting being homeless (95% CI: 34-43%), a level that was consistent over 2 years. As of August 2020, 15% of the cohort was homeless (95% CI: 10-20%; relative risk [RR] 0.40, 95% CI: 0.28, 0.55; p<0.001). During a period of assertive public health efforts to reduce COVID-19 risk through provision of housing, we found meaningful reductions in homelessness in this sample of vulnerable women.

Breaking down relationship barriers to increase PrEP uptake and adherence among adolescent girls and young women in Kenya: safety and preliminary effectiveness results from a pilot cluster-randomized trial.

INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) has the potential to reduce HIV acquisition among adolescent girls and young women (AGYW) in sub-Saharan Africa, a priority population for epidemic control. However, intimate partner violence (IPV) and low relationship power can create significant challenges to PrEP use. The Tu'Washindi intervention aimed to increase PrEP use by addressing relationship- and violence-related barriers among AGYW enrolled in the DREAMS Initiative in Siaya County, Kenya. METHODS: Our multi-level, community-based intervention was piloted in a cluster-randomized controlled trial conducted at six DREAMS sites from April to December 2019 (NCT03938818). Three intervention components were delivered over 6 months: an eight-session empowerment-based support club, community sensitization targeted towards male partners and a couples' PrEP education event. Participants were ages 17-24, HIV negative and either eligible for, or already taking, PrEP. Over 6 months of follow-up, we assessed IPV (months 3 and 6) and PrEP uptake and continuation (month 6) through interviewer-administered questionnaires; PrEP adherence was assessed with Wisepill electronic monitoring devices. These outcomes were compared using adjusted Poisson and negative binomial regression models. RESULTS: We enrolled 103 AGYW with median age of 22 years (IQR 20-23); one-third were currently taking PrEP and 45% reported IPV in the past 3 months. Retention was 97% at month 6. Compared to the control arm, intervention arm participants were more likely to initiate PrEP, if not already using it at enrolment (52% vs. 24%, aRR 2.28, 95% CI 1.19-4.38, p = 0.01), and those taking PrEP had more days with device openings (25% of days vs. 13%, aRR 1.94, 95% CI 1.16-3.25, p = 0.01). Twenty percent of participants reported IPV during follow-up. There were trends towards fewer IPV events (aIRR 0.66, 95% CI 0.27-1.62, p = 0.37) and fewer events resulting in injury (aIRR 0.21, 95% CI 0.04-1.02, p = 0.05) in the intervention versus control arm. CONCLUSIONS: Tu'Washindi shows promise in promoting PrEP uptake and adherence among AGYW without concomitant increases in IPV; however, adherence was still suboptimal. Further research is needed to determine whether these gains translate to increases in the proportion of AGYW with protective levels of PrEP adherence and to evaluate the potential for the intervention to reduce IPV risk.

Impact of a high-volume overdose prevention site on social and drug disorder in surrounding areas in San Francisco.

BACKGROUND: Between January and December 2022 a multi-service center incorporating an overdose prevention site (OPS) operated with city government sanction in San Francisco. One concern often expressed about OPS is that they may increase social nuisance associated with drug use in the surrounding area, despite international evidence that this is not the case. METHODS: We conducted systematic street observation of 10 indicators of drug- and homelessness-related social nuisance in a 500 m radius around the OPS and around a comparison point in the same city before and after the introduction of the OPS. We estimated the risk that any given street within sampling areas would have nuisance post-intervention relative to the control area using Poisson regression. RESULTS: Ratio of relative risks of any reported nuisance in the 500 m area surrounding the OPS from pre- to post-intervention to that of the comparison area was 0.69 (95% CI: 0.54, 0.87; p=0.002). The relative risk of drug-specific nuisance was similar to the comparison area pre/post intervention (0.90; 95% CI 0.66, 1.24; p=0.53). The risk of homelessness-specific nuisance decreased around the OPS (RR 0.7., 95% CI 0.52, 0.93; p=0.02) whereas they increased around the comparison area (RR 1.33, 95% CI 1.06, 1.68; p=0.02). CONCLUSION: We found that implementing authorized OPS services in a U.S. city did not increase the prevalence of visible signs of drug use and homelessness in the surrounding area. These findings are similar to those found at OPS outside the U.S.

Evaluating oxygen monitoring and administration during overdose responses at a sanctioned overdose prevention site in San Francisco, California: A mixed-methods study.

BACKGROUND: Overdose prevention sites (OPSs) are spaces where individuals can use pre-obtained drugs and trained staff can immediately intervene in the event of an overdose. While some OPSs use a combination of naloxone and oxygen to reverse overdoses, little is known about oxygen as a complementary tool to naloxone in OPS settings. We conducted a mixed methods study to assess the role of oxygen provision at a locally sanctioned OPS in San Francisco, California. METHODS: We used descriptive statistics to quantify number and type of overdose interventions delivered in 46 weeks of OPS operation in 2022. We used qualitative data from OPS staff interviews to evaluate experiences using oxygen during overdose responses. Interviews were coded and thematically analyzed to identify themes related to oxygen impact on overdose response. RESULTS: OPS staff were successful in reversing 100% of overdoses (n = 333) during 46 weeks of operation. Oxygen became available 18 weeks after opening. After oxygen became available (n = 248 overdose incidents), nearly all involved oxygen (91.5%), with more than half involving both oxygen and naloxone (59.3%). Overdoses involving naloxone decreased from 98% to 66%, though average number of overdoses concomitantly increased from 5 to 9 per week. Interviews revealed that oxygen improved overdose response experiences for OPS participants and staff. OPS EMTs were leaders of delivering and refining the overdose response protocol and trained other staff. Challenges included strained relationships with city emergency response systems due to protocol requiring 911 calls after all naloxone administrations, inconsistent supplies, and lack of sufficient staffing causing people to work long shifts. CONCLUSIONS: Although the OPS operated temporarily, it offered important insights. Ensuring consistent oxygen supplies, staffing, and removing 911 call requirements after every naloxone administration could improve resource management. These recommendations may enable success for future OPS in San Francisco and elsewhere.

"My Family Was Also Happy": Couples' Qualitative Reports of a Combined Behavioral Economics and Cognitive Behavioral Therapy Intervention to Reduce Alcohol Use and Intimate Partner Violence.

Improving intimate partner violence interventions requires understanding pathways to change among couples participating in these interventions. This article presents qualitative data from 18 males and 16 females who participated in a combined behavioral economics (contingency management) and cognitive behavioral therapy alcohol and violence reduction intervention trial in Bengaluru, India. Results confirmed several theorized pathways of change, as well as identified further mechanisms through which the intervention supported the change. These included the emotional impacts of incentives, perceived and actual accountability via breathalyzers and family involvement, and enhanced support gained through counseling skills. Findings reveal critical insights into intervention design for future implementation.

Nonurgent Emergency Department Use Among Women Sentenced to Probation.

Like women who are incarcerated, women sentenced to probation have high levels of physical and mental health morbidities. They rely heavily on hospital emergency departments (EDs) for health care in community settings. We examined the prevalence of nonurgent ED use in a cohort of women with a history of probation system involvement in Alameda County, California. We found that two-thirds of ED visits were nonurgent, even though most women had health insurance. Factors associated with nonurgent ED use included having one or more chronic health conditions, severe substance use, low health literacy, and recent arrest. Among a subgroup of women who also received primary care, dissatisfaction with a recent primary care visit was also associated with nonurgent ED use. The heavy use of the ED for nonurgent care in this study may reflect a need to provide options better attuned to the multiple forms of instability and barriers to wellness faced by women with criminal legal system involvement.

Incorporating end-users' voices into the development of an implant for HIV prevention: a discrete choice experiment in South Africa and Zimbabwe.

BACKGROUND: Input from end-users during preclinical phases can support market fit for new HIV prevention technologies. With several long-acting pre-exposure prophylaxis (PrEP) implants in development, we aimed to understand young women's preferences for PrEP implants to inform optimal design. METHODS: We developed a discrete choice experiment and surveyed 800 young women in Harare, Zimbabwe and Tshwane, South Africa between September-November 2020. Women aged 18-30 years who were nulliparous, postpartum, or exchanged sex for money, goods or shelter in prior year were eligible; quotas were set for each subgroup. The DCE asked participants to choose between two hypothetical implants for HIV prevention in a series of nine questions. Implants were described by: size, number of rods and insertion sites, duration (6-months, 1-year, 2-years), flexibility, and biodegradability. Random-parameters logit models estimated preference weights. RESULTS: Median age was 24 years (interquartile range 21-27). By design, 36% had used contraceptive implants. Duration of protection was most important feature, with strong preference for a 2-year over 6-month implant. In Zimbabwe, the number of rods/insertion sites was second most important and half as important as duration. Nonetheless, to achieve an implant lasting 2-years, 74% were estimated to accept two rods, one in each arm. In South Africa, preference was for longer, flexible implants that required removal, although each of these attributes were one-third as important as duration. On average, biodegradability and size did not influence Zimbabwean women's choices. Contraceptive implant experience and parity did not influence relative importance of attributes. CONCLUSIONS: While duration of protection was a prominent attribute shaping women's choices for PrEP implants, other characteristics related to discreetness were relevant. Optimizing for longest dosing while also ensuring minimal detection of implant placement seemed most attractive to potential users.

The Effects of Participation in an Intensive HIV Prevention Trial on Long-Term Socio-Demographic Outcomes Among Young Women in Rural South Africa.

BACKGROUND: Research trial participation may influence health outcomes regardless of the intervention assigned, but is often not assessed. SETTING: We investigated how participation in an HIV prevention trial (the HIV Prevention Trials Network (HPTN) 068 study) affected health outcomes 4 years after the study in adolescent girls and young women in South Africa beyond effects of the tested intervention. METHODS: We developed an analytical cohort that included the HIV Prevention 068 trial (HPTN 068) trial participants from the Agincourt Health and Demographic Surveillance System and resembled HPTN 068 trial enrollees (aged 13-20 years and in grades 8-11 in 2011) using inverse probability of treatment weights. We estimated risk differences for the association between trial participation and education and early parity (age <20 years) in 2019, after accounting for differences at baseline between the trial participants and nonparticipants. RESULTS: There were 3442 young women enrolled in grades 8-11 in 2011; 1669 were in the HPTN 068 trial. Trial participants were more likely to have completed secondary school by 2019 (adjusted RD (aRD) 5.0%, 95% confidence interval (CI) 2.2%, 7.9%; 82.3% in trial participants vs. 77.2% in nonparticipants). Trial participants had similar risk of parity before age 20 compared with nontrial participants (aRD 2.3%, 95% CI: -0.8%, 5.5%). CONCLUSIONS: Trial participation did not seem to influence early parity, but did increase educational attainment. Our results are compatible with an explanation of Hawthorne effects from trial participation on schooling behaviors that were small, but observable even 4 years after the end of the trial.

Couples' decision making regarding the use of multipurpose prevention technology (MPT) for pregnancy and HIV prevention.

We conducted a secondary analysis of discrete choice experiment (DCE) data from 395 couples enrolled in the Microbicide Trials Network (MTN)-045/CUPID study in Uganda and Zimbabwe to understand couple decision making around choice of multipurpose prevention technologies (MPTs) to prevent both HIV and pregnancy. Members of couples completed the same DCE, first separately then jointly, choosing between two hypothetical MPTs in a series of nine questions. Most couples either had similar preferences at the outset or had equal decision-making around MPTs (62%). Couples with male influence (17%) were more likely to use contraceptive pills with a male partner's knowledge and couples with female influence (21%) were less likely to have shared decision making about family planning. Males influenced discussion around MPT duration, side effects, menstrual changes, and how the vagina feels during sex. Decision making was relatively shared, though decisions around certain attributes were more likely to be dominated by male partners.

Using narratives to inform the development of a digital health intervention related to COVID-19 vaccination in Black young adults in Georgia, North Carolina and Alabama.

Interactive stories are a relatively newer form of storytelling with great potential to correct misinformation while increasing self-efficacy, which is crucial to vaccine acceptance. To address COVID-19 vaccine hesitancy and medical mistrust in young Black adults (BYA), we sought to adapt a pre-existing application ("app"; Tough Talks) designed to address HIV disclosure decision-making through choose-your-own adventure (CYOA) narratives and other activities. The adapted app (Tough Talks - COVID) uses a similar approach to situate COVID-19 vaccination decision-making within social contexts and to encourage greater deliberation about decisions. To inform content for the CYOA narratives, we conducted an online survey that was used to elicit the behavioral, cognitive, and environmental determinants influencing COVID-19 vaccine hesitancy among 150 BYA (ages 18-29) in Georgia, Alabama, and North Carolina. The survey included scenario questions that were developed with input from a youth advisory board to understand responses to peer and family influences. In two scenarios that involved discussions with family and friends about vaccination status, most respondents chose to be honest about their vaccination status. However, vaccinated individuals perceived more social pressure and stigma about not being vaccinated than unvaccinated respondents who were not as motivated by social pressure. Personal choice/agency in the face of perceived vaccine risks was a more common theme for unvaccinated respondents. Results suggest that relying on changing social norms alone may not impact barriers to vaccination in unvaccinated young adults without also addressing other barriers to vaccination such as concerns about autonomy and vaccine safety. Based on these findings, CYOA narratives in the app were adapted to include discussions with family and friends but also to touch on themes of personal choice as well as other topics that influence behaviors besides norms such as safety, side effects, and risk of COVID-19 in an evolving pandemic.

Social environment risk factors for violence, family context, and trajectories of social-emotional functioning among Latinx adolescents.

INTRODUCTION: High social-emotional functioning, including emotion regulation and nonviolent conflict resolution, constitute developmental competencies of adolescence that promote health and well-being. We used prospective longitudinal data from a predominantly Latinx population to understand how family context and social environment risk factors for violence related to patterns of social-emotional functioning during the transition between middle school and high school. METHODS: We prospectively interviewed 599 8th graders every 6 months for 2 years. We used trajectory models to explore longitudinal patterns of emotion regulation and nonviolent problem solving and multinomial regression to distinguish how these groups were associated with family context, partner and peer gang involvement, and neighborhood social disorder. RESULTS: Youth reporting lower neighborhood disorder in 8th grade were more likely to be in the high emotion regulation trajectory group. Youth without exposure to gangs through peers and partners in 8th grade were more likely to be in the high nonviolent problem-solving skills trajectory group. Family cohesion was associated with being in the high trajectory groups for both emotional regulation and problem-solving skills. CONCLUSION: Emotion regulation and nonviolent problem-solving skills had different associations with the social environment risk factors for violence examined, indicating that mechanisms of influence and strategies for intervention may vary. The association between problem-solving skills and exposure to gangs through peers and partners shows that social norms may be important targets of change. Additionally, interventions with parents that build family cohesion during adolescence may buffer environmental exposures that shape adolescents' ability to practice protective social-emotional behaviors.

Exploring Motivations for COVID-19 Vaccination Among Black Young Adults in 3 Southern US States: Cross-sectional Study.

BACKGROUND: Few studies have focused on attitudes toward COVID-19 vaccination among Black or African American young adults (BYA) in the Southern United States, despite high levels of infection in this population. OBJECTIVE: To understand this gap, we conducted an online survey to explore beliefs and experiences related to COVID-19 vaccination among BYA (aged 18-29 years) in 3 southern states. METHODS: We recruited 150 BYA to participate in an online survey as formative research for an intervention to address vaccine hesitancy in Alabama, Georgia, and North Carolina from September 22, 2021, to November 18, 2021. Participants were recruited through social media ads on Facebook, Twitter, Instagram, and YouTube. Additionally, we distributed information about the survey through organizations working with BYA in Alabama, Georgia, and North Carolina; our community partners; and network collaborations. We used measures that had been used and were previously validated in prior surveys, adapting them to the context of this study. RESULTS: Roughly 28 (19%) of the participants had not received any doses of the COVID-19 vaccine. Half of the unvaccinated respondents (n=14, 50%) reported they wanted to wait longer before getting vaccinated. Motivators to get vaccinated were similar between unvaccinated and vaccinated respondents (eg, if required, to protect the health of others), but the main motivator for those vaccinated was to protect one's own health. Among unvaccinated individuals, reasons for not receiving the COVID-19 vaccine included concern about vaccine side effects (n=15, 54%) and mistrust of vaccine safety (n=13, 46%), of effectiveness (n=12, 43%), and of the government's involvement with vaccines (n=12, 43%). Experiences of discrimination (n=60, 40%) and mistrust of vaccines (n=54, 36%) were common overall. Among all respondents, those who said they would be motivated to get vaccinated if it was required for school, work, or travel were more likely to endorse negative beliefs about vaccines compared to those motivated for other reasons. CONCLUSIONS: Mistrust in COVID-19 vaccine safety and efficacy is common among BYA in the Southern United States, irrespective of vaccination status. Other motivators, such as safety of family and community and vaccination requirements, may be able to tip the scales toward a decision to be vaccinated among those who are initially hesitant. However, it is unclear how vaccine requirements among BYA in the South affect trust in the government or health care in the long term. Interventions that include BYA in vaccination messaging and programs may more proactively build feelings of trust and combat misinformation.

Couples' Preferences for "2 in 1" Multipurpose Prevention Technologies to Prevent Both HIV and Pregnancy: Results of a Discrete Choice Experiment in Uganda and Zimbabwe.

End-user input early in biomedical product development may optimize design to support high uptake and adherence. We interviewed 400 couples (800 total participants) in Uganda and Zimbabwe to assess their preferences for multipurpose prevention technologies (MPTs) for HIV and pregnancy prevention. Using a discrete choice experiment, couples made a series of choices between hypothetical MPTs, including oral tablets and vaginal rings, inserts, and films and completed an interviewer-administered questionnaire assessing sociodemographic and behavioral measures. Most couples preferred presented MPTs over male condoms. Couples' MPT choices in both countries were influenced most by the combination of product form and dosing frequency, with monthly dosing preferred over daily. Analysis highlighted differences by country as to which side effects were most important: Ugandan couples placed greater importance on effects on the vaginal environment during sex, whereas Zimbabwean couples placed more importance on changes to menstruation and other side effects (headache, cramps). Couples' preferences signaled an openness to new product forms and more frequent dosing if preferred characteristics of other attributes were achieved.

The CHARISMA Randomized Controlled Trial: A Relationship-Focused Counseling Intervention Integrated Within Oral PrEP Delivery for HIV Prevention Among Women in Johannesburg, South Africa.

BACKGROUND: Consistent use of oral pre-exposure prophylaxis (PrEP) has been a challenge among women, particularly when in relationships with lack of partner support or intimate partner violence (IPV). METHODS: We conducted a randomized controlled trial (RCT) of an empowerment counseling intervention called "CHARISMA" delivered to women within a PrEP demonstration project in Johannesburg, South Africa. The trial tested the effectiveness of CHARISMA to increase PrEP adherence; decrease social harms and IPV; and improve partnership dynamics (eg, communication, disclosure and support) compared with those who received the standard of care counselling support and referrals. Four hundred seven HIV-seronegative, nonpregnant women aged 18-45 years were enrolled for 6 months of PrEP use, with 203 randomized (1:1) to the intervention. All participants reporting IPV received counseling and referrals that followed the WHO five-step Listen, Inquire, Validate, Enhance Safety, and Support approach. RESULTS: This RCT did not identify statistically significant differences between study arms for PrEP adherence or relationship dynamics, with the exception of an increase in PrEP disclosure among intervention arm women. In our study, we cannot determine whether the lack of detectable findings may have been because of lack of intervention effect, strength of standard of care services, low risk in the study population, or other factors. CONCLUSIONS: Addressing IPV and relationship dynamics remain important factors influencing HIV risk, and addressing these within the context of PrEP delivery is an important synergistic opportunity. CHARISMA was highly acceptable to participants, and further adaptation and testing of the intervention to other populations and settings will augment the evidence base.

Patterns of Adherence to a Dapivirine Vaginal Ring for HIV-1 Prevention Among South African Women in a Phase III Randomized Controlled Trial.

BACKGROUND: Persistent use of HIV prevention methods can be a challenge, particularly for some younger women. The long-acting, discreet, woman-centric dapivirine vaginal ring offers promise as a prevention method with less user burden, which could support continued use. We assessed dapivirine vaginal ring use to understand adherence patterns and identify characteristics influencing patterns. SETTING: Participants enrolled in South Africa in the MTN-020/ASPIRE randomized placebo-controlled trial. METHODS: We used group-based trajectory modeling to identify clusters of participants with similar longitudinal patterns of adherence in the last year of participation and potential predictors of group membership. Women with at least 1 year of follow-up were included (n = 626). RESULTS: Five adherence patterns were identified: (1) consistently high, 34%, (2) consistently moderate, 34%, (3) consistently low, 16%, (4) decreasing, 9%, and (5) increasing, 7%. Women younger than 22 years [adjusted odds ratio (AOR) 1.8, 95% confidence interval (CI): 1.0 to 3.0], using an intrauterine device (AOR 3.3, 95% CI: 1.4 to 7.8) or oral contraceptives (AOR 3.9, 95% CI: 1.7 to 8.9), experiencing menses (AOR 1.8, 95% CI: 1.1 to 3.0), and who reported inconsistent condom use (AOR 1.8, 95% CI: 1.0 to 3.3) were more likely to be classified as consistently low compared to consistently high (referent). CONCLUSIONS: Most South African women successfully persisted with a moderate or high level of use. Encouraging ring replacement with completion of menses may help to decrease concerns about hygiene and improve persistence. Associations between contraception and persistent low adherence suggest efforts may be needed to ensure contraceptive method choice does not interfere with ring use.

Early Sexual Debut and Neighborhood Social Environment in Latinx Youth.

OBJECTIVES: To examine whether social aspects of the neighborhood environment are associated with early sexual initiation in a California agricultural community of predominantly Latinx adolescents. METHODS: In a prospective cohort study of 599 eighth graders recruited from middle schools in Salinas, California (2015-2019), participants completed five interviews over 2 years. Social environment measures included neighborhood social dynamics (neighborhood disorder, social cohesion, and social network gang exposure); experiences of discrimination; and school connectedness. We estimated associations between baseline social environment and early sexual initiation (<15 years) using Poisson regression with robust standard errors. We compared contraceptive self-efficacy and attitudes by sexual initiation status using ANOVA. RESULTS: Most youth were Latinx (94%) and age 13 (70%) at enrollment; 53% were female and 49% had a parent employed in agriculture. Additionally, 14% reported first vaginal sex before age 15. Neighborhood disorder (relative risk [RR], 1.13; 95% confidence interval [CI], 1.05-1.21), social network gang exposure (RR, 2.23; 95% CI, 1.49-3.33), and experiences of discrimination (RR, 1.67 [1-2 events versus none], 95% CI, 1.09-2.55; RR, 2.33 [3+ events versus none], 95% CI, 1.07-4.64) were associated with early sexual initiation. School connectedness was protective (RR, 0.44, 95% CI, 0.29-0.69). Youth who initiated sex before age 15 had more negative birth control attitudes and expressed lower motivation to use contraceptives. CONCLUSIONS: Findings underscore opportunities to promote early adolescent sexual health through strengthening supportive and safe neighborhood environments with the promise of addressing disparities in unintended pregnancy and sexually transmitted infection rates in later adolescence.