Biomedical HIV Prevention Research Research Articles

Assessing Facilitator Fidelity to Principles of Public Deliberation: Tutorial.

Public deliberation, or deliberative democracy, is a method used to elicit informed perspectives and justifiable solutions to ethically fraught or contentious issues that affect multiple stakeholder groups with conflicting interests. Deliberative events bring together stakeholders (deliberants) who are provided with empirical evidence on the central issue or concern and then asked to discuss the evidence, consider the issue from a societal perspective, and collectively work toward a justifiable resolution. There is increasing interest in this method, which warrants clear guidance for evaluating the quality of its use in research. Most of the existing literature on measuring deliberation quality emphasizes the quality of deliberants' inputs (eg, engagement and evidence of compromise) during deliberative sessions. Fewer researchers have framed quality in terms of facilitator inputs, and these researchers tend to examine inputs that are consistent with generic group processes. The theory, process, and purpose of public deliberation, however, are distinct from those of focus groups or other group-based discussions and warrant a mechanism for measuring quality in terms of facilitator fidelity to the principles and processes of deliberative democracy. In our public deliberation on ethical conflicts in minor consent for biomedical HIV prevention research, we assessed facilitator fidelity to these principles and processes because we believe that such assessments serve as a component of a comprehensive evaluation of overall deliberation quality. We examined verbatim facilitator remarks in the deliberation transcripts and determined whether they aligned with the 6 principles of public deliberation: equal participation, respect for the opinions of others, adoption of a societal perspective, reasoned justification of ideas, expression of diverse opinions, and compromise or movement toward consensus. In this tutorial, we describe the development of a blueprint to guide researchers in assessing facilitator fidelity, share 3 templates that will assist them in the task, and describe the results of our assessment of facilitator fidelity in 1 of the 4 sites in which we conducted deliberations.

94. Implementing Online Public Deliberations on Minor Consent for Biomedical HIV Prevention Research in Diverse Cities

94. Implementing Online Public Deliberations on Minor Consent for Biomedical HIV Prevention Research in Diverse Cities

Parental Engagement in Consent Processes for Enrollment in Biomedical HIV Prevention Trials: Implications for Minor Adolescents' Willingness to Participate

PurposeMinor adolescents are often excluded from HIV prevention clinical trials due to unresolved ethical issues. Their under-representation in research leads to delayed access to new HIV prevention approaches. We examine the relationship between consent procedures, trial features, demographic and social characteristics, and minor adolescents' willingness to participate (WTP) in biomedical HIV prevention research. MethodsWe recruited 14–17-year-olds at risk of HIV for this quasi-experimental study. Adolescents were randomly assigned to (1) self-consent, (2) adult permission required, or (3) parental permission required and underwent simulated consent procedures for two types of HIV prevention trials. They rated likelihood of participating in each study if offered the opportunity and completed a survey with demographic, social, and behavioral measures. ResultsOne hundred and twenty nine adolescents with diverse identities and socioeconomic status enrolled. Among the 58% of participants who identified as lesbian, gay, bisexual, transgender, or queer (LGBTQ), 76% were out to at least one parent/guardian (outness). Mean WTP was 3.6 (of 5; 5 = definitely would participate) across all participants and both trial types. We found no evidence of an association between WTP and consent condition, LGBTQ identity, or outness. However, medical mistrust, communication with parents, and concern about HIV were associated with WTP. DiscussionOur results suggest adolescents are willing to participate in HIV prevention trials and parental involvement in the consent process may not be the most important deciding factor. However, variation in WTP within consent groups, and variation in other significant variables, underscores the need for individualized approaches to recruitment and consent for these trials.

Ethical considerations for involving adolescents in biomedical HIV prevention research

BackgroundInvolvement of adolescent girls in biomedical HIV research is essential to better understand efficacy and safety of new prevention interventions in this key population at high risk of HIV infection. However, there are many ethical issues to consider prior to engaging them in pivotal biomedical research. In Uganda, 16–17-year-old adolescents can access sexual and reproductive health services including for HIV or other sexually transmitted infections, contraception, and antenatal care without parental consent. In contrast, participation in HIV prevention research involving investigational new drugs requires adolescents to have parental or guardian consent. Thus, privacy and confidentiality concerns may deter adolescent participation. We describe community perspectives on ethical considerations for involving adolescent girls in the MTN 034 study in Uganda.MethodsFrom August 2017 to March 2018, we held five stakeholder engagement meetings in preparation for the MTN 034 study in Kampala, Uganda (NCT03593655): two with 140 community representatives, two with 125 adolescents, and one with 50 adolescents and parents. Discussions were moderated by the study team. Proceedings were documented by notetakers. Summary notes described community perspectives of adolescent participation in HIV research including convergent, divergent or minority views, challenges, and proposed solutions.ResultsMost community members perceived parental or guardian consent as a principal barrier to study participation due to concerns about adolescent disclosure of pre-marital sex, which is a cultural taboo. Of 125 adolescent participants, 119 (95%) feared inadvertent disclosure of sexual activity to their parents. Community stakeholders identified the following critical considerations for ethical involvement of adolescents in HIV biomedical research: (1) involving key stakeholders in recruitment, (2) ensuring confidentiality of sensitive information about adolescent sexual activity, (3) informing adolescents about information to be disclosed to parents or guardians, (4) offering youth friendly services by appropriately trained staff, and (5) partnering with community youth organizations to maximize recruitment and retention.ConclusionsStakeholder engagement with diverse community representatives prior to conducting adolescent HIV prevention research is critical to collectively shaping the research agenda, successfully recruiting and retaining adolescents in HIV clinical trials and identifying practical strategies to ensure high ethical standards during trial implementation.

Gender and Power Dynamics of Social Relationships Shape Willingness to Participate in Biomedical HIV Prevention Research Among South African Adolescents and Young Adults.

Background: Understanding young women and men's perceived barriers and facilitators to participation in biomedical HIV prevention research is important for designing youth friendly services (YFS) and acceptable technologies, which are necessary for preventing high sustained HIV incidence in South Africa. This study explores the multileveled barriers and facilitators to young men and women's willingness to participate in hypothetical biomedical HIV prevention research.Methods: Eight age- (16–18 and 19–24 years) and gender-stratified focus group discussions (FGDs) were conducted using semi-structured interview guides to explore young South African women and men's willingness, perceived barriers, and facilitators to participating in biomedical HIV prevention research. FGD transcripts were uploaded to NVivo and coded collaboratively with youth study team members. Thematic analysis using Bronfenbrenner's ecological model (individual, inter-personal, community, and societal) was used to guide a deductive coding procedure, which was documented and compared by gender.Results: Thirty-one participants from Durban and 34 from Soweto participated in FGDs. Individual facilitators for participation were discussed more by young men and included financial incentives and altruism. Concerns about side-effects of biomedical products were a common barrier. Interpersonal relationships with peers, intimate partners and caregivers influenced young people's willingness to participate in HIV prevention research, more so among young women. For young women, gendered power dynamics and distrust of intimate partners and parents influenced both communication regarding participation and willingness to participate in research that is often stigmatized, due to societal norms around women's sexuality. On a societal level, participants expressed distrust in medical and research institutions, however a sense of community that was developed with the study staff of this project, was a motivator to participate in future studies.Discussion: At each level of the ecological model, we found participants expressed gendered barriers and facilitators for participation. Gender norms as well as distrust of partners, parents, and health care professionals were key barriers that cut across all levels. At each level participants discussed facilitators that were youth-engaged, underscoring the need to implement YFS, establish trust and address gender inequities within future biomedical HIV prevention studies wishing to engage and retain South African youth.

Homo adhaerens: Risk and adherence in biomedical HIV prevention research.

After the turn of the millennium, HIV clinical researchers pivoted from developing and testing new antiretrovirals (ARVs) for treatment, to reconfiguring the same molecules for pre-exposure prophylaxis (PrEP). In 2012, Truvada became the first HIV therapy to also be approved by the FDA for PrEP, regarded as a magic bullet that promised to end the epidemic. However, six years after its approval, it continues to be inaccessible to those who are most vulnerable. In this article, I critically analyze HIV PrEP clinical trials, dissecting the novel techniques researchers use to demonstrate efficacy. I argue that in making sense of the interplay between adherence to a prophylactic regimen and risk for HIV, biomedical HIV prevention research has revealed a new subject of biopolitics, Homo adhaerens. In the early 2000s, clinical researchers operating in the Global South identified Homo adhaerens as the ideal subject, one who embodies both high-risk behavior and diligent adherence to a daily oral regimen. I trace the construction of Homo adhaerens to the United States, where I listen closely to activists engaged with the ongoing DISCOVER trial of PrEP. Activists either aspire for Homo adhaerens as a standard, making the liberal argument that expanding access could make PrEP successful, or they rebuke the framework of clinical research that produces narrow understandings of adherence, efficacy, and universality. Ultimately, I argue that by failing to grapple with the social realities that underlie poor adherence, PrEP clinical trials produce knowledge that is not useful for those who are most vulnerable.

Views among Malawian women about joining HIV prevention clinical trials when pregnant

BackgroundThe pressing need to expand the biomedical HIV prevention evidence base during pregnancy is now increasingly recognized. Women’s views regarding participation in such trials and initiating PrEP while pregnant are critical to inform evolving policy and best practices aimed at responsibly expanding evidence-based access for this population.MethodsWe conducted 35 semi-structured interviews with reproductive-aged women in Malawi in the local language, Chichewa. Participants were HIV-negative and purposively sampled to capture a range of experience with research during pregnancy. Women’s perspectives on enrolling in three hypothetical HIV prevention trial vignettes while pregnant were explored, testing: (1) oral PrEP (Truvada) (2) a vaginal ring (dapivirine), and (3) a randomized trial comparing the two. The vignettes were read aloud to participants and a simple visual was provided. Interviews were audio-recorded, transcribed, translated, and coded using NVivo 11. Thematic analysis informed the analytic approach.ResultsA majority of women accepted participation in all trials. Women’s views on research participation varied largely based on their assessment of whether participation or nonparticipation would best protect their own health and that of their offspring. Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation—principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low. Women who were uninterested in participating highlighted potential maternal and fetal health risks of the trial, challenges of justifying prevention use to their partner, and raised some modality-specific concerns. Women also described ways their social networks, sense of altruism and adherence requirements would influence participation decisions.ConclusionsThe majority of participants conveyed strong interest in participating in biomedical HIV prevention research during pregnancy, largely motivated by a desire to protect themselves and their offspring. Our results are consistent with other studies that found high acceptance of HIV prevention products during pregnancy, and support the current direction of HIV research policies and practices that are increasingly aimed at protecting the health of pregnant women and their offspring through responsible research, rather than defaulting to their exclusion.

How Biomedical HIV Prevention Trials Incorporate Behavioral and Social Sciences Research: A Typology of Approaches

In the field of biomedical HIV prevention, researchers have meaningfully incorporated behavioral and social sciences research (BSSR) into numerous clinical trials, though the timing and degree of integration have been highly variable. The literature offers few frameworks that systematically characterize these collaborations. To fill this gap, we developed a typology of BSSR approaches within biomedical HIV prevention research. Focusing on trials that had safety and/or efficacy endpoints, we identified five approaches for combining BSSR and clinical research: formative, embedded, parallel, explanatory, and implications. We describe each approach and provide illustrative examples. By offering a shared vocabulary for distinguishing the timing and design of collaborative BSSR and clinical research, this typology can facilitate greater transparency in collaborators’ expectations and responsibilities, and help collaborators address challenges likely to be associated with such interdisciplinary research.

"Free Testing and PrEP without Outing Myself to Parents:" Motivation to participate in oral and injectable PrEP clinical trials among adolescent men who have sex with men.

BackgroundAdolescent men who have sex with men (AMSM) account for disproportionately high numbers of new HIV diagnoses. Non-adherence to daily use limiting the effectiveness of oral PrEP (Truvada) has led to current trials with adult MSM testing Cabotegravir, a long-term injectable medication. Once comparative studies with young adult MSM have established relative safety and efficacy of these medications, there will be a need for such comparative trials involving adolescents. Trends in state laws and IRB protocol review indicate that many of these studies will permit youth to provide independent consent for participation. Understanding the motivations of AMSM to participate in HIV biomedical prevention studies is important to ensure their agreement is voluntary without misunderstanding and undue influence. This study examined AMSM attitudes toward participation in oral/injectable PrEP RCTs to inform protections of youth’s rights and welfare in future studies.MethodsWe administered to 198 ethnically diverse U.S. AMSM, 14–17 years, a web-based survey including demographic and sexual health questions, description of a year-long oral versus injectable PrEP RCT and 26 Likert-type and one open-ended item assessing motivations for and against participation including: perceived benefits and risks of PrEP; free HIV/STI testing and counseling; confidentiality concerns; random assignment; and benefit to others.ResultsSixty-two percent indicated they were likely to participate in the study. The majority endorsed daily HIV protection, free HIV/STI testing, sexual health counseling, not having to rely on partner’s condom use, and altruism as reasons to participate. Reasons against participation included medication side effects, concern taking the pill daily and clinic visits would reveal their sexual orientation and behaviors to parents. Over half erroneously assumed they would be assigned to the condition best for them and 39% indicated free access to services would lead them to participate even if they did not want to. Multiple regression indicated these factors accounted for 55% of the variance in participation choice. Nether age or ethnicity yielded significance.ConclusionsResults suggest future biomedical HIV prevention research will need to develop procedures to address AMSM’s confidentiality concerns, enhance youth’s understanding of random assignment, the continued importance of medication adherence and partner condom use during trial participation, and availability of alternative sexual health services to avoid the potentially undue influence of access to free sexual health services.

Perspectives on biomedical HIV prevention options among women who inject drugs in Kenya

ABSTRACTDue to heightened vulnerability to HIV from frequent engagement in sex work and overlapping drug-using and sexual networks, women who inject drugs should be a high priority population for pre-exposure prophylaxis (PrEP) and other biomedical HIV prevention tools. Kenya is one of the first African countries to approve oral PrEP for HIV prevention among “key populations,” including people who inject drugs and sex workers. The objective of this study was to explore preferences and perceived challenges to PrEP adoption among women who inject drugs in Kisumu, Kenya. We conducted qualitative interviews with nine HIV-uninfected women who inject drugs to assess their perceptions of biomedical HIV interventions, including oral PrEP, microbicide gels, and intravaginal rings. Despite their high risk and multiple biomedical studies in the region, only two women had ever heard of any of these methods. All women were interested in trying at least one biomedical prevention method, primarily to protect themselves from partners who were believed to have multiple other sexual partners. Although women shared concerns about side effects and product efficacy, they did not perceive drug use as a significant deterrent to adopting or adhering to biomedical prevention methods. Beginning immediately and continuing throughout Kenya’s planned PrEP rollout, efforts are urgently needed to include the perspectives of high risk women who use drugs in biomedical HIV prevention research and programing.

HIVR4P 2016, Partnering for Prevention: Conference Summary and Highlights.

HIV Research for Prevention: AIDS Vaccine, Microbicide, and ARV-based Prevention Science (HIVR4P) was built on a growing consensus that effective HIV prevention requires a combination of approaches and that understanding, analyzing, and debating the cross-cutting issues that impact prevention research are all essential to combat the global HIV/AIDS epidemic. To that end, the biennial HIVR4P conference is dedicated to all biomedical HIV prevention research approaches, including HIV vaccines, microbicides, pre-exposure prophylaxis, and treatment as prevention. The HIVR4P 2016 conference was held in Chicago, Illinois (USA), on October 17–21, and included more than 700 scientific presentations and 21 satellite sessions covering the latest and most promising advances across the HIV prevention research field. The theme “Partnering for Prevention” represented the conference's commitment to breaking down silos between research disciplines as well as between researchers, program developers, care providers, advocates, communities, and funders. Delegates spanning 42 countries attended the conference. One-third of those in attendance were early career investigators, which reflects a firm commitment to emerging researchers and ultimately to the goal of developing a sustainable scientific enterprise well into the future. This article presents a concise summary of highlights from the conference. For a more detailed account, one may find full abstracts, daily summaries, and webcasts on the conference website at hivr4p.org.

Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents

ABSTRACTBackground: Biomedical HIV prevention research with minors is complicated by the requirement of parental consent, which may disclose sensitive information to parents. We examine the experience of principal investigators (PIs) and study personnel who faced this complex ethical issue in the first biomedical HIV prevention study that allowed minors to self-consent for enrollment. Methods: We conducted in-depth interviews with PIs and study personnel from 13 medical trial sites in cities across the United States. Data were analyzed using a conventional content analysis. Results: Participants experienced moral conflict as they struggled to fulfill conflicting duties in this trial involving minor adolescents with multiple vulnerabilities. Our participants experienced conflict between the two types of duties—protective and scientific—previously identified by Merritt. Protective duties were owed to the child, the parents, and the institution, and participants expressed tension between the actions that would protect these subgroups and the actions necessary to fulfill their scientific duties. Conclusions: Moral conflict was resolved in a variety of ways, including reflecting on the protocol's alignment with federal regulations, modifying consent language, considering each individual for enrollment carefully, and accepting institutional review board (IRB) decisions. Potential solutions for future studies are discussed, and include flexible protocol consent procedures and centralized IRB reviews.

25. Adolescent Self-Consent for Biomedical HIV Prevention Research: Implications for Protocol Approval and Implementation

25. Adolescent Self-Consent for Biomedical HIV Prevention Research: Implications for Protocol Approval and Implementation

Factors that Influence Trainees' Acquisition of Knowledge about Biomedical HIV Prevention Research: Experience from the Field

AIDS Research and Human RetrovirusesVol. 30, No. S1 Community Engagement and AdvocacyFactors that Influence Trainees' Acquisition of Knowledge about Biomedical HIV Prevention Research: Experience from the FieldOluwatosin Bamidele Alaka, Morenike Oluwatoyin Ukpong, Florita Durueke, and Augustina Obiajulu AmuamuziamOluwatosin Bamidele AlakaNew HIV Vaccine and Microbicide Advocacy Society, Programmes, Lagos, NigeriaSearch for more papers by this author, Morenike Oluwatoyin UkpongNew HIV Vaccine and Microbicide Advocacy Society, Coordinator / Programmes, Lagos, NigeriaSearch for more papers by this author, Florita DuruekeNew HIV Vaccine and Microbicide Advocacy Society, Programmes, Lagos, NigeriaSearch for more papers by this author, and Augustina Obiajulu AmuamuziamNew HIV Vaccine and Microbicide Advocacy Society, Programmes, Lagos, NigeriaSearch for more papers by this authorPublished Online:30 Oct 2014https://doi.org/10.1089/aid.2014.5179.abstractAboutSectionsView articleView Full TextPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View article"Factors that Influence Trainees' Acquisition of Knowledge about Biomedical HIV Prevention Research: Experience from the Field." AIDS Research and Human Retroviruses, 30(S1), p. A97FiguresReferencesRelatedDetails Volume 30Issue S1Oct 2014 InformationCopyright 2014, Mary Ann Liebert, Inc.To cite this article:Oluwatosin Bamidele Alaka, Morenike Oluwatoyin Ukpong, Florita Durueke, and Augustina Obiajulu Amuamuziam.Factors that Influence Trainees' Acquisition of Knowledge about Biomedical HIV Prevention Research: Experience from the Field.AIDS Research and Human Retroviruses.Oct 2014.A97-A97.http://doi.org/10.1089/aid.2014.5179.abstractPublished in Volume: 30 Issue S1: October 30, 2014PDF download

Getting to zero the biomedical way in Africa: outcomes of deliberation at the 2013 Biomedical HIV Prevention Forum in Abuja, Nigeria.

BackgroundOver the last few decades, biomedical HIV prevention research had engaged multiple African stakeholders. There have however been few platforms to enable regional stakeholders to engage with one another. In partnership with the World AIDS Campaign International, the Institute of Public Health of Obafemi Awolowo University, and the National Agency for the Control of AIDS in Nigeria, the New HIV Vaccine and Microbicide Advocacy Society hosted a forum on biomedical HIV prevention research in Africa. Stakeholders’ present explored evidences related to biomedical HIV prevention research and development in Africa, and made recommendations to inform policy, guidelines and future research agenda.DiscussionThe BHPF hosted 342 participants. Topics discussed included the use of antiretrovirals for HIV prevention, considerations for biomedical HIV prevention among key populations; HIV vaccine development; HIV cure; community and civil society engagement; and ethical considerations in implementation of biomedical HIV prevention research. Participants identified challenges for implementation of proven efficacious interventions and discovery of other new prevention options for Africa. Concerns raised included limited funding by African governments, lack of cohesive advocacy and policy agenda for biomedical HIV prevention research and development by Africa, varied ethical practices, and limited support to communities’ capacity to actively engaged with clinical trial conducts. Participants recommended that the African Government implement the Abuja +12 declaration; the civil society build stronger partnerships with diverse stakeholders, and develop a coherent advocacy agenda that also enhances community research literacy; and researchers and sponsors of trials on the African continent establish a process for determining appropriate standards for trial conduct on the continent.ConclusionBy highlighting key considerations for biomedical HIV prevention research and development in Africa, the forum has helped identify key advocacy issues that Civil Society can expend efforts on so as to strengthen support for future biomedical HIV prevention research on the continent.

Biomedical HIV prevention research and epidemic control in Thailand: two sides of the same coin.

For a country with a moderate adult HIV prevalence of just over 1% in 2012, Thailand is widely perceived as having made some extraordinary contributions to the global management of the HIV/AIDS pandemic. It has been promoted as a model of effective HIV control and applauded for its leadership in providing access to antiretroviral treatment. Thailand has also received international recognition for its contribution to biomedical HIV prevention research, which is generally perceived as exceptional. In this paper, Thailand's global role model function as an example of effective HIV/AIDS control and high-quality biomedical HIV prevention research is re-evaluated against the background of currently available data and more recent insights. The results indicate that Thailand's initial response in raising the level of the political significance of HIV/AIDS was indeed extraordinary, which probably prevented a much larger epidemic from occurring. However, this response transpired in unusual extraconstitutional circumstances and its effectiveness declined once the country returned to political normalcy. Available data confirm the country's more than exceptional contribution to biomedical HIV prevention research. Thailand has made a huge contribution to the global management and control of the HIV/AIDS pandemic.

Implementing good participatory practice guidelines in the FEM-PrEP Preexposure Prophylaxis Trial for HIV Prevention among African Women: a focus on local stakeholder involvement

Implementing good participatory practice guidelines in the FEM-PrEP Preexposure Prophylaxis Trial for HIV Prevention among African Women: a focus on local stakeholder involvement Natasha Mack,1 Stella Kirkendale,1 Paul Omullo,2 Jacob Odhiambo,2 Malebo Ratlhagana,3 Martha Masaki,4 Phumzile Siguntu,5 Kawango Agot,2 Khatija Ahmed,3 Saidi Kapiga,4 Johan Lombaard,5 Lut Van Damme,1 Amy Corneli1 1FHI 360, Durham, NC, USA; 2Impact Research and Development Organization, Bondo, Kenya; 3Setshaba Research Centre, Soshanguve, South Africa; 4Kilimanjaro Christian Medical Center, Moshi, Tanzania; 5Josha Research, Bloemfontein, South Africa Abstract: Biomedical HIV-prevention research is most likely to succeed when researchers actively engage with community stakeholders. To this effect, the Joint United Nations Programme on HIV/AIDS and the AIDS Vaccine Advocacy Coalition developed good participatory practice guidelines for biomedical HIV-prevention trials in 2007 and updated them in 2011. The Preexposure Prophylaxis Trial for HIV Prevention among African Women (FEM-PrEP) clinical trial, testing once-daily Truvada as preexposure prophylaxis among women at higher risk of HIV in Kenya, South Africa, and Tanzania, included a community program to engage with local stakeholders. Following the trial, we revisited the community program to situate activities in the context of the 2011 guidelines. In the paper, we describe implementation of the six guidelines relevant to local stakeholder engagement – stakeholder advisory mechanisms, stakeholder engagement plan, stakeholder education plan, communications plan, issues management plan, trial closure, and results dissemination – in light of on-the-ground realities of the trial. We then identify two cross-cutting themes from our considerations: (1) stakeholder education beyond the good participatory practice recommendation to increase research literacy about the specific trial is needed; education efforts should also communicate a base of information on HIV transmission and prevention; and (2) anticipatory preparation is useful in communications planning, issues management, and trial closure and results dissemination, and may contribute to successful conduct of the trial; in FEM-PrEP, this was possible through integration of the community program with social, behavioral, and clinical research. Keywords: stakeholder engagement, community engagement, community involvement, HIV-prevention trials, good participatory practice guidelines, FEM-PrEP

Acceptability of Oral versus Rectal HIV Preexposure Prophylaxis among Men Who Have Sex with Men and Transgender Women in Peru

Oral preexposure prophylaxis (PrEP) with antiretrovirals (ARVs) is at the forefront of biomedical HIV prevention research, and ARVs are also being tested for rectal administration to target people practicing unprotected receptive anal intercourse (URAI) and at risk of HIV infection. This study assessed the acceptability of daily oral PrEP and rectal PrEP during URAI among men who have sex with men (MSM) and transgender women (TGW) in Peru. During the 2008 HIV sentinel surveillance survey conducted in 3 Peruvian cities (Lima, Iquitos, and Pucallpa), MSM and TGW reported being "versatile," "most of the time receptive," and "exclusively receptive" during anal sex behavior where surveyed on their acceptability of oral and rectal PrEP. Among 532 individuals, high acceptance of either oral (96.2%) or rectal (91.7%) PrEP products was reported. If both products were efficacious/available, 28.6% would prefer a pill, 57.3% a rectal lubricant, and 14.1% either. A trend toward higher acceptance was observed as receptive anal sex behavior exclusivity rose (P = .013). Being receptive most of the time (adjusted odds ratio [aOR]: 9.1, P = .01) and exclusively receptive (aOR: 7.5, P = .01), compared to being versatile, were independently associated with oral PrEP acceptability. A similar association was found with the acceptability of rectal formulations (aOR: 2.3, P = .07; and aOR: 2.5, P = .02; respectively). Oral and rectal PrEP were highly acceptable among Peruvian MSM and TGW, particularly among those at the highest HIV infection risk. These data can guide the implementation of PrEP programs in Peru and similar settings and populations.

Ethics of medical care and clinical research: a qualitative study of principal investigators in biomedical HIV prevention research

In clinical research there is a tension between the role of a doctor, who must serve the best interests of the patient, and the role of the researcher, who must...

An assessment of Good Participatory Practice Guidelines at HIV prevention research clinical centers in Eastern and Southern Africa

Background Compliance with ethical, regulatory, and scientific guidelines does not always guarantee consideration of external stakeholders’ concerns in research. In 2007, UNAIDS and AVAC: Global Advocacy for HIV Prevention developed the Good Participatory Practice (GPP) Guidelines to ensure community and stakeholder engagement in biomedical HIV prevention research. In 2010-2011, the International AIDS Vaccine Initiative (IAVI) and AVAC conducted the first comprehensive evaluation of perceptions, practices and recommendations for improvement of participatory practice at eight IAVI-sponsored research centers (RCs) in Eastern and Southern Africa.