scholarly journals An Intervention by and for Transgender Women Living With HIV: Study Protocol for a Two-Arm Randomized Controlled Trial Testing the Efficacy of “Healthy Divas” to Improve HIV Care Outcomes

2021 ◽  
Vol 3 ◽  
Author(s):  
Jae M. Sevelius ◽  
Torsten B. Neilands ◽  
Cathy J. Reback ◽  
Danielle Castro ◽  
Samantha E. Dilworth ◽  
...  
Keyword(s):  
Social Services ◽  
San Francisco ◽  
Controlled Trial ◽  
Transgender Women ◽  
Hiv Treatment ◽  
Hiv Care ◽  
Randomized Controlled ◽  
Women Living With Hiv ◽  
Institutional Review ◽  
Living With Hiv

Introduction: Transgender women (assigned “male” at birth but who do not identify as male) are disproportionately impacted by HIV and experience unique barriers and facilitators to HIV care engagement. In formative work, we identified culturally specific and modifiable barriers to HIV treatment engagement among transgender women living with HIV (TWH), including prioritizing transition-related healthcare over HIV treatment, avoiding HIV care settings due to gender-related and HIV stigma, concerns about potential drug interactions with hormones, and inadequate social support. Grounded in the investigators' Models of Gender Affirmation and Health Care Empowerment, we developed the Healthy Divas intervention to optimize engagement in HIV care among TWH at risk for treatment failure and consequential morbidity, mortality, and onward transmission of HIV.Methods and Analysis: We conducted a 2-arm randomized controlled trial (RCT) of the intervention's efficacy in Los Angeles and San Francisco to improve engagement in care among TWH (N = 278). The primary outcome was virologic control indicated by undetectable HIV-1 level (undetectability = < 20 copies/mL), at baseline and follow-up assessment for 12 months at 3-month intervals.Ethics and Dissemination: This study was approved by University of California, San Francisco Institutional Review Board (15-17910) and Western Institutional Review Board (20181370). Participants provided informed consent before enrolment in the study. We are committed to collaboration with National Institutes of Health officials, other researchers, and health and social services communities for rapid dissemination of data and sharing of materials. The results will be published in peer-reviewed academic journals and scientific presentations. We will make our results available to researchers interested in transgender health to avoid unintentional duplication of research, as well as to others in health and social services communities, including HIV clinics, LGBT community-based organizations, and AIDS service organizations.Clinical Trial Registration:Clinicaltrials.gov, identifier NCT03081559.

scholarly journals The FANMI (“my FAMILY” in Creole) study to evaluate community-based cohort care for adolescent and young women living with HIV in Haiti: protocol for a randomized controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Grace Seo ◽  
Joseph Marie Bajo Joseph ◽  
Nancy Confident ◽  
Esther Jean ◽  
Bianca Louis ◽  
...  
Keyword(s):  
Risk Behaviors ◽  
Adolescent Girls ◽  
Young Women ◽  
Controlled Trial ◽  
Retention In Care ◽  
Hiv Care ◽  
Community Based ◽  
Randomized Controlled ◽  
Women Living With Hiv ◽  
Living With Hiv

Abstract Background Adolescent girls and young women living with HIV in resource-limited settings have the poorest health outcomes of any age group, due in part to poor retention in care. Differentiated models of HIV care that target the specific challenges of young people living with HIV are urgently needed. Methods The FANMI study is an unblinded randomized controlled trial designed to evaluate the efficacy of an adolescent-specific model of HIV care in Port-au-Prince, Haiti. The FANMI intervention places newly young women living with HIV who are not currently on ART or on ART ≤ 3 months, in cohorts of 5–10 peers to receive monthly group HIV care in a community location. In contrast, participants in the standard care arm receive routine HIV care and individual counseling each month in GHESKIO’s Adolescent Clinic. A total of 160 participants ages 16–23 years old are being randomized on a 1:1 basis. The primary outcome is retention in HIV care defined as being alive and in care at 12 months after enrollment. Secondary outcomes include viral suppression at 12 months, sexual risk behaviors, acceptability of the FANMI intervention, and health care utilization and costs. Discussion The FANMI study evaluates a novel community-based cohort model of HIV care aimed at improving retention in care and reducing risk behaviors for HIV transmission among adolescent girls and young women living with HIV. Specifically, the FANMI model of care addresses social isolation by placing participants in cohorts of 5–10 peers to provide intensified peer support and makes HIV health management a group norm; reduces stigma and improves convenience by providing care in a community setting; and integrates clinical care and social support by the same providers to streamline care and promote long-term patient-provider relationships. If shown to be effective, the FANMI intervention may serve as a model of HIV care for improving retention among hard-to-reach adolescents and young adults in Haiti and could be adapted for other high-risk groups globally. Trial registration Identifier: NCT03286504, Registered September 18, 2017.

scholarly journals Feasibility and Acceptability of the Modified Antiretroviral Treatment Access Study (MARTAS) Intervention Based on a Pilot Study in Ukraine

2019 ◽  
Vol 18 ◽  
pp. 232595821882325 ◽  
Author(s):  
Oleksandr Neduzhko ◽  
Oleksandr Postnov ◽  
Trista Bingham ◽  
Janet J. Myers ◽  
Timothy Flanigan ◽  
...  
Keyword(s):  
Antiretroviral Treatment ◽  
Controlled Trial ◽  
Hiv Treatment ◽  
Small Sample ◽  
Hiv Care ◽  
Treatment Intervention ◽  
Treatment Access ◽  
Individual Level ◽  
Randomized Controlled ◽  
High Satisfaction

We conducted a pilot of the Modified Antiretroviral Treatment Access Study (MARTAS), a linkage to HIV treatment intervention, prior to implementing a multisite randomized controlled trial (RCT) in Ukraine. The objectives of the pilot were to assess the feasibility and acceptability of the MARTAS intervention among a small sample of adults recently diagnosed with HIV at specialty clinics in the Mykolaiv region of Ukraine in 2015. The adapted intervention consisted of up to 6 individual-level sessions with a linkage coordinator (nurse) over a 90-day period. Overall, 22 persons participated in the pilot. On average, participants received 4.2 sessions and 14 participants linked to HIV care within 3 months of study enrollment. All 18 participants who completed the acceptability survey expressed high satisfaction with their interaction with their linkage coordinator. The results of the pilot demonstrated feasibility and acceptability of the MARTAS intervention in advance of a larger scale RCT in Ukraine.

scholarly journals A Cluster Randomized Controlled Trial Evaluating the Efficacy of Peer Mentors to Support South African Women Living with HIV and Their Infants

PLoS ONE ◽  
2014 ◽  
Vol 9 (1) ◽  
pp. e84867 ◽  
Author(s):  
Mary Jane Rotheram-Borus ◽  
Linda M. Richter ◽  
Alastair van Heerden ◽  
Heidi van Rooyen ◽  
Mark Tomlinson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
South African ◽  
Controlled Trial ◽  
African Women ◽  
Peer Mentors ◽  
Randomized Controlled ◽  
Women Living With Hiv ◽  
Cluster Randomized ◽  
South African Women ◽  
Living With Hiv
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