Recruitment for Retention in Biomedical HIV Prevention Studies: Strategies, Challenges, Lessons Learned from MTN-020 (ASPIRE) Study, at Kampala Site

Background Despite the high burden of new HIV infections in minor adolescents, they are often excluded from biomedical HIV prevention trials, largely owing to the ethical complexities of obtaining consent for enrollment. Researchers and ethics regulators have a duty to protect adolescents—as a special category of human subjects, they must have protection that extends beyond those afforded to all human subjects. Typically, additional protection includes parental consent for enrollment. However, parental consent can present a risk of harm for minor adolescents. Research involving minor adolescents indicate that they are unwilling to join biomedical trials for stigmatized health problems, such as HIV, when parental consent is required. This presents a significant barrier to progress in adolescent HIV prevention by creating delays in research and the translation of new scientific evidence generated in biomedical trials in adult populations. Objective This protocol aims to examine how parental involvement in the consent process affects the acceptability of hypothetical participation in biomedical HIV prevention trials from the perspectives of minor adolescents and parents of minor adolescents. Methods In this protocol, we use a quasi-experimental design that involves a simulated consent process for 2 different HIV prevention trials. The first trial is modeled after an open-label study of the use of tenofovir disoproxil fumarate and emtricitabine as preexposure prophylaxis for HIV. The second trial is modeled after a phase IIa trial of an injectable HIV integrase inhibitor. There are 2 groups in the study—minor adolescents aged 14 to 17 years, inclusive, and parents of minor adolescents in the same age range. The adolescent participants are randomized to 1 of 3 consent conditions with varying degrees of parental involvement. After undergoing a simulated consent process, they rate their willingness to participate (WTP) in each of the 2 trials if offered the opportunity. The primary outcome is WTP, given the consent condition. Parents undergo a similar process but are asked to rate the acceptability of each of the 3 consent conditions. The primary outcome is acceptability of the consent method for enrollment. The secondary outcomes include the following: capacity to consent among both participant groups, the prevalence of medical mistrust, and the effects of the study phase (eg, phase IIa vs the open-label study) and drug administration route (eg, oral vs injection) on WTP (adolescents) and acceptability (parents) of the consent method. Results Enrollment began in April 2018 and ended mid-September 2019. Data are being analyzed and dissemination is expected in April 2020. Conclusions The study will provide the needed empirical data about minor adolescents’ and parents’ perspectives on consent methods for minors. The evidence generated can be used to guide investigators and ethics regulators in the design of consent processes for biomedical HIV prevention trials. International Registered Report Identifier (IRRID) DERR1-10.2196/16509

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Prevalence and Correlates of Transactional Sex Among Women of Low Socioeconomic Status in Portland, Oregon

10.21203/rs.3.rs-30004/v1 ◽

2020 ◽

Author(s):

Timothy W Menza ◽

Lauren Lipira ◽

Amisha Bhattarai ◽

Victoria Cali-DeLeon ◽

Roberto Orellana

Keyword(s):

Socioeconomic Status ◽

Hiv Prevention ◽

Sexual Violence ◽

Childhood Trauma ◽

Low Socioeconomic Status ◽

Transactional Sex ◽

Hiv Screening ◽

Low Socioeconomic ◽

Biomedical Hiv Prevention ◽

Exposure Prophylaxis

Abstract Background: Women who report transactional sex are at increased risk for HIV and other sexually transmitted infections (STIs). However,in the United States, social, behavioral, and trauma-related vulnerabilities associated with transactional sex are understudied and data on access to biomedical HIV prevention among women who report transactional sex is limited. Methods: In 2016, we conducted a population-based, cross-sectional survey of women of low socioeconomic status recruited via respondent-driven sampling in Portland, Oregon. We calculated the prevalence and,assessed the correlates of, transactional sex using generalized linear models accounting for sampling design. We also compared health outcomes,HIV screening, and knowledge and uptake of HIV pre-exposure prophylaxis (PrEP) between women who did and did not report transactional sex.Results: Of 334 women, 13.6% reported transactional sex (95% confidence interval [CI]: 6.8%, 20.5%). Women who reported transactional sex were older, more likely to identify as black, to identify as lesbian or bisexual, to experience childhood trauma and recent sexual violence, and to have been homeless. Six percent(95%CI: 1.8%, 10.5%) of women with no adverse childhood experiences (ACEs) reported transactional sex compared to 23.8%(95%CI: 13.0%, 34.6%)of women who reported eleven ACEs (P<0.001). Transactional sex was strongly associated withcombination methamphetamine and opiate use as well ascondomless sex. Women who reported transactional sex were more likely to report being diagnosed with a bacterial STI and hepatitis C; however, HIV screening and pre-exposure prophylaxis knowledge and use were low. Conclusions:In a sample ofwomen of low socioeconomic status in Portland, Oregon, transactional sex was characterized by marginalized identities, homelessness, childhood trauma, sexual violence, substance use, and sexual vulnerability to HIV/STI. Multi-level interventions that address these social, behavioral, and trauma-related factors and increase access to biomedical HIV prevention are critical to the sexual health of women who engage in transactional sex.

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Lessons Learned from Longer Acting Reversible Contraception Applied to Longer Acting HIV Prevention Technologies

Current HIV/AIDS Reports ◽

10.1007/s11904-021-00571-0 ◽

2021 ◽

Author(s):

Rachel Logan ◽

Dominika Seidman

Keyword(s):

Hiv Prevention ◽

Reproductive Health ◽

Sexual Health ◽

Lessons Learned ◽

Reproductive Justice ◽

Holistic View ◽

Marginalized Communities ◽

Exposure Prophylaxis

Abstract Purpose of Review This review describes lessons learned from longer acting contraception and employs a reproductive justice lens to inform expansion of emerging HIV prevention technologies. Recent Findings Reproductive justice is a framework that advocates for the promotion of universal sexual and reproductive freedoms, particularly among historically marginalized communities. This framework takes a holistic view of individuals and sees the interconnections between sexual health, reproductive health, and overall health. Employing a sexual and reproductive justice perspective is essential to understanding and helping to mitigate the role intersecting structural, sexual, and reproductive oppressions, including those demonstrated through promotion of longer acting contraception, and can critically inform rollout of future prevention technologies, such as longer acting HIV pre-exposure prophylaxis. Summary This review highlights the need for researchers, clinicians, and policymakers to apply lessons learned from contraception and specifically focuses on principles of reproductive justice to offer expanding HIV prevention options.

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