Meta-analysis of Pregnancy Events in Biomedical HIV Prevention Trials in Sub-Saharan Africa: Implications for Gender Transformative Trials.

Historically, pregnant and lactating populations (PLP) have been excluded or disenrolled from biomedical HIV prevention trials, despite being more likely to acquire HIV during pregnancy and the post-partum period. We conducted a meta-analysis of pregnancy events in biomedical HIV prevention trials in sub-Saharan Africa to support trialists moving toward more inclusive clinical and implementation studies. We searched peer-reviewed literature reporting pregnancy events and contraceptive requirements in HIV prevention trials between 2001 and 2022.

Ethical research when abortion access is legally restricted.

Risks and benefits of some clinical research may be altered.

Exploring intersectional stigma and COVID-19 impact on human immunodeficiency virus service provision for African Americans in a Southern city.

Aims/objectives: Through interviews with clinical service providers, we explored stigma's impact on HIV service provision for African Americans during COVID-19.

Background: African Americans experience disproportionate rates of HIV and COVID-19. We explored COVID-19's impact on HIV services for African American adults in a Southern city.

Left ventricular assist devices: A comprehensive review of major clinical trials, devices, and future directions.

Heart failure is an increasingly prevalent medical condition associated with significant morbidity and mortality. In spite of optimal medical therapy, a large number of patients continue to deteriorate clinically and could potentially benefit from advanced therapies. While cardiac transplantation is an established therapy for end-stage heart failure, there are a limited number of donor hearts, and many patients may not be candidates.

Molecular mechanisms underlining the role of metformin as a therapeutic agent in lung cancer.

Background: Metformin, a first-line therapeutic for type 2 diabetes, has been studied for its potential use in cancer treatment following a number of epidemiological studies that have demonstrated reduced cancer incidence and mortality rates among patients treated with the drug. As yet, however, there remains significant uncertainty about the molecular mechanisms by which metformin exerts its anti-cancer effects. Herein, we summarize the evidence surrounding the anti-lung cancer effects of metformin.

Surgical Treatment for Ischemic Heart Failure (STICH) trial: A review of outcomes.

Coronary artery disease (CAD) is a significant source of morbidity and mortality in developed countries. The landmark Surgical Treatment for Ischemic Heart Failure (STICH) trial has provided greatly needed evidence in the management of patients with severe left ventricle (LV) dysfunction (LVEF ≤ 35%) and CAD amenable to revascularization. The trial investigated two primary hypotheses: (i) that coronary artery bypass grafting (CABG) with optimal medical therapy (OMT) was superior to OMT alone, and (ii) that CABG with surgical ventricular reconstruction (SVR) would be superior to CABG alone.

Using theory of change frameworks to develop evaluation strategies for research engagement: results of a pre-pilot study.

Introduction: Inadequate community and stakeholder engagement can lead to accusations that research is unethical and can delay or slow research or translation of results to practice. Such experiences have led major funders as well as regulatory and advisory bodies to establish minimal requirements for community and stakeholder engagement in HIV and other clinical research. However, systematic efforts to formally evaluate the contributions and impact of particular practices are lacking.

Rapid organizational network analysis to assess coordination of services for HIV testing clients: an exploratory study.

Recognizing that HIV testing provides a gateway opportunity to connect with at-risk populations, we explored an approach to collect, analyze and present data on the network of connections between HIV testing organizations and other health and social service agencies operating in Durham County, NC. We surveyed 26 health and social service organizations, including 6 providing HIV testing services, and presented the results including frequency tabulations, network visualizations and metrics, and GIS maps to the participating organizations. Mapping the landscape of organizational relationships was seen as a practical and expedient approach to facilitating cross-sector collaborative efforts to improve community health.

Optimizing adherence in HIV prevention product trials: Development and psychometric evaluation of simple tools for screening and adherence counseling.

Background: Low adherence in recent HIV prevention clinical trials highlights the need to better understand, measure, and support product use within clinical trials. Conventional self-reported adherence instruments within HIV prevention trials, often relying on single-item questions, have proven ineffective. While objective adherence measures are desirable, none currently exist that apply to both active and placebo arms.

Attitudes and perceptions towards novel objective measures of ARV-based vaginal ring use: Results from a global stakeholder survey.

Results of recent microbicide and pre-exposure prophylaxis clinical trials have shown adherence to be a significant challenge with new HIV prevention technologies. As the vaginal ring containing dapivirine moves into two open label follow-on studies (HOPE/MTN-025 and DREAM) and other antiretroviral-based and multi-purpose prevention technology ring products advance through the development pipeline, there is a need for more accurate and reliable measures of adherence to microbicide ring products. We previously conducted a comprehensive landscape analysis to identify new technologies that could be applied to adherence measurement of vaginal rings containing antiretrovirals.

Corrigendum: Relationship between Human Immunodeficiency Virus (HIV) Knowledge, HIV-Related Stigma, and HIV Testing among Young Black Adults in a Southeastern City.

[This corrects the article on p. 47 in vol. 5, PMID: 28349049.

Secrecy, empowerment and protection: positioning PrEP in KwaZulu-Natal, South Africa.

The release of World Health Organisation guidelines recommending the prophylactic use of daily Truvada for all populations at high risk of acquiring HIV opens the way for implementation of oral pre-exposure prophylaxis (PrEP). The impact of new prevention technologies is, however, dependent on demand creation strategies such as user awareness, acceptability and access, which in turn are influenced by sociocultural and gender norms. This study was conducted in three locations in KwaZulu-Natal, urban, rural and peri-urban, with six participatory workshops.

Relationship between Human Immunodeficiency Virus (HIV) Knowledge, HIV-Related Stigma, and HIV Testing among Young Black Adults in a Southeastern City.

The southeast is identified as the epicenter of the nation's human immunodeficiency virus (HIV) epidemic, accounting for nearly 44% of all persons living with a HIV diagnosis in the United States. HIV stigma and knowledge have been cited as some of the complex factors increasing risk of acquiring HIV within African-American communities. We sought to understand how HIV knowledge and HIV-related stigma impact HIV testing experience among young Black adults who completed a community-based participatory research survey in a Southeastern city.

Social Context of Adherence in an Open-Label 1 % Tenofovir Gel Trial: Gender Dynamics and Disclosure in KwaZulu-Natal, South Africa.

CAPRISA 008, an open-label extension study of tenofovir gel with coitally-related dosing, provided an opportunity to explore the relationship between product adherence and gender dynamics in a context where women knew they were receiving an active product with evidence of HIV prevention effectiveness. Interviews with 63 CAPRISA 008 participants and 13 male partners in KwaZulu-Natal, South Africa, highlighted that the process of negotiating gel use was determined in part by relationship dynamics including the duration of the relationship, the living situation, an evaluation of the relationship (e.g.

Developing a Framework for Evaluating Ethical Outcomes of Good Participatory Practices in TB Clinical Drug Trials.

Good Participatory Practice Guidelines for TB Drug Trials (GPP-TB) were issued in 2012, based on similar guidelines for HIV prevention and reflecting growing acceptance of the importance of community engagement and participatory strategies in clinical research. Though the need for such strategies is clear, evaluation of the benefits and burdens are needed. Working with a diverse group of global TB stakeholders including advocates, scientists, and ethicists, we used a Theory of Change approach to develop an evaluation framework for GPP-TB that includes a clearly defined ethical goal, a set of powerful strategies derived from GPP-TB practices for achieving the goal, and outcomes connecting strategies to goal.

Biomarkers and biometric measures of adherence to use of ARV-based vaginal rings.

Introduction: Poor adherence to product use has been observed in recent trials of antiretroviral (ARV)-based oral and vaginal gel HIV prevention products, resulting in an inability to determine product efficacy. The delivery of microbicides through vaginal rings is widely perceived as a way to achieve better adherence but vaginal rings do not eliminate the adherence challenges exhibited in clinical trials. Improved objective measures of adherence are needed as new ARV-based vaginal ring products enter the clinical trial stage.

Concurrency and Other Sexual Risk Behaviors Among Black Young Adults in a Southeastern City.

Black Americans continue to have higher rates of HIV disease than other races/ethnicities. Conventional individual-level risk behaviors do not fully account for these racial/ethnic disparities. Sexual concurrency may help explain them.

Evaluating community engagement in global health research: the need for metrics.

Background: Community engagement in research has gained momentum as an approach to improving research, to helping ensure that community concerns are taken into account, and to informing ethical decision-making when research is conducted in contexts of vulnerability. However, guidelines and scholarship regarding community engagement are arguably unsettled, making it difficult to implement and evaluate.

Discussion: We describe normative guidelines on community engagement that have been offered by national and international bodies in the context of HIV-related research, which set the stage for similar work in other health related research.

HIV Testing Experience and Risk Behavior Among Sexually Active Black Young Adults: A CBPR-Based Study Using Respondent-Driven Sampling in Durham, North Carolina.

African Americans are disproportionately affected by the HIV epidemic inclusive of men who have sex with men, heterosexual men, and women. As part of a community-based participatory research study we assessed HIV testing experience among sexually active 18-30 year old Black men and women in Durham, NC. Of 508 participants, 173 (74 %) men and 236 (86 %; p = 0.

Trial participation disclosure and gel use behavior in the CAPRISA 004 tenofovir gel trial.

Disclosure, or open communication, by female microbicide trial participants of their trial participation and use of an investigational HIV prevention drug to a sexual partner may affect participants' trial product usage behavior and contribute to poor adherence. With mixed results from recent microbicide clinical trials being linked to differing participant adherence, insights into the communication dynamics between trial participants and their sexual partners are particularly important. We examined the quantitative association between (1) communication of trial participation to a partner and participant adherence to gel and (2) communication of trial participation to a partner and participant HIV status.

The sexual risk context among the FEM-PrEP study population in Bondo, Kenya and Pretoria, South Africa.

Background: Incidence rates in the FEM-PrEP and VOICE trials demonstrate that women from diverse sub-Saharan African communities continue to be at substantial HIV risk.

Objective: To describe and compare the sexual risk context of the study population from two FEM-PrEP trial sites-Bondo, Kenya, and Pretoria, South Africa.

Methods: At baseline we collected information about demographics, sexual behaviors, and partnership beliefs through quantitative questionnaires with all participants (Bondo, n = 720; Pretoria, n = 750).