scholarly journals HIV-related stigma and universal testing and treatment for HIV prevention and care: design of an implementation science evaluation nested in the HPTN 071 (PopART) cluster-randomized trial in Zambia and South Africa

2016 ◽  
Vol 31 (10) ◽  
pp. 1342-1354 ◽  
Author(s):  
James R Hargreaves ◽  
Anne Stangl ◽  
Virginia Bond ◽  
Graeme Hoddinott ◽  
Shari Krishnaratne ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Randomized Trial ◽  
Qualitative Data ◽  
Cluster Randomized Trial ◽  
People Living With Hiv ◽  
Universal Testing ◽  
Prevention And Treatment ◽  
Related Stigma ◽  
Cluster Randomized ◽  
Living With Hiv

Abstract Background : Stigma and discrimination related to HIV and key populations at high risk of HIV have the potential to impede the implementation of effective HIV prevention and treatment programmes at scale. Studies measuring the impact of stigma on these programmes are rare. We are conducting an implementation science study of HIV-related stigma in communities and health settings within a large, pragmatic cluster-randomized trial of a universal testing and treatment intervention for HIV prevention in Zambia and South Africa and will assess how stigma affects, and is affected by, implementation of this intervention. Methods/Design : A mixed-method evaluation will be nested within HIV prevention trials network (HPTN) 071/PopART (Clinical Trials registration number NCT01900977), a three-arm trial comparing universal door-to-door delivery of HIV testing and referral to prevention and treatment services, accompanied by either an immediate offer of anti-retroviral treatment to people living with HIV regardless of clinical status, or an offer of treatment in-line with national guidelines, with a standard-of-care control arm. The primary outcome of HPTN 071/PopART is HIV incidence measured among a cohort of 52 500 individuals in 21 study clusters. Our evaluation will include integrated quantitative and qualitative data collection and analysis in all trial sites. We will collect quantitative data on indicators of HIV-related stigma over 3 years from large probability samples of community members, health workers and people living with HIV. We will collect qualitative data, including in-depth interviews and observations from members of these same groups sampled purposively. In analysis, we will: (1) compare HIV-related stigma measures between study arms, (2) link data on stigma to measures of the success of implementation of the PopART intervention and (3) explore changes in the dominant drivers and manifestations of stigma in study communities and the health system. Discussion : HIV-related stigma may impede the successful implementation of HIV prevention and treatment programmes. Using a novel study-design nested within a large, community randomized trial we will evaluate the extent to which HIV-related stigma affects and is affected by the implementation of a comprehensive combination HIV prevention intervention including a universal test and treatment approach.

scholarly journals Protocol paper: Stepped wedge cluster randomized trial translating the ABCS into optimizing cardiovascular care for people living with HIV

2020 ◽  
Vol 63 (2) ◽  
pp. 125-133 ◽  
Author(s):  
Stephen K. Williams ◽  
Brent A. Johnson ◽  
Jonathan N. Tobin ◽  
Amneris Esther Luque ◽  
Mechelle Sanders ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
People Living With Hiv ◽  
Stepped Wedge ◽  
Cluster Randomized ◽  
Living With Hiv ◽  
Cardiovascular Care

scholarly journals HIV Prevention for Black Heterosexual Men: The Barbershop Talk with Brothers Cluster Randomized Trial

2019 ◽  
Vol 109 (8) ◽  
pp. 1131-1137 ◽  
Author(s):  
Tracey E. Wilson ◽  
Yolene Gousse ◽  
Michael A. Joseph ◽  
Ruth C. Browne ◽  
Brignel Camilien ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Heterosexual Men ◽  
Cluster Randomized ◽  
Black Heterosexual Men

scholarly journals Title: Keep It Up! 3.0: Study Protocol for a Type III Hybrid Implementation-Effectiveness Cluster-Randomized Trial

2020 ◽  
Author(s):  
Brian Mustanski ◽  
Justin Patrick Jones ◽  
Kathryn Macapagal ◽  
Nanette Benbow ◽  
Dennis H. Li ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Randomized Trial ◽  
Young Men ◽  
Cluster Randomized Trial ◽  
The United States ◽  
Community Based ◽  
Direct To Consumer ◽  
Community Based Organization ◽  
Sex With Men ◽  
Cluster Randomized

Abstract BackgroundYoung men who have sex with men are disproportionately impacted by the HIV epidemic in the United States. Few rigorously tested HIV prevention interventions have been developed for young men who have sex with men; previous interventions have primarily focused on in-person programming, with high variability in fidelity. With nearly all young men who have sex with men going online daily, eHealth approaches to prevention may successfully bridge research and practice. Keep It Up! is an eHealth HIV Prevention program for young men who have sex with men. Previous research has demonstrated its effectiveness in reducing sexually transmitted infections and condomless anal sex and efficiency in delivering HIV prevention education. Aim 1 is to compare two strategies for implementing KIU—implementation in community-based organizations and a centralized direct-to-consumer recruitment arm. Aim 2 is to examine adoption characteristics which explain variability in implementation success. Our exploratory aim will develop recommendations and materials for sustainment of KIU after completion of the trial.MethodsThis is a Type III Hybrid Effectiveness-Implementation cluster randomized trial. Using estimates of young men who have sex with men per county in the United States, we identified 113 counties for our sample frame. Using an iterative process, we selected 66 counties to randomize 2:1 to our two strategies in Aim 1. The RE-AIM model for implementation science will be used to drive our outcome measurements in reach, effectiveness, implementation variability, and cost. Outcome measures will be collected from community-based organization staff participants, young men who have sex with men participants, and the technology provider. Our second aim will use mixed-methods research mapped onto the domains of the consolidated framework for implementation research. DiscussionThe trial has launched and is ongoing. This study is among the first to use a cluster randomized trial design in HIV implementation science. In comparing the community-based organization and direct to consumer models for recruitment and ongoing participant engagement, we are examining two strategies which have shown effectiveness in delivering health and technology interventions in the past, but with little base knowledge on their comparative advantages and disadvantages in implementation. The results of the trial will further understanding of the implementation of eHealth prevention interventions.Trial RegistrationNCT03896776, clinicaltrials.gov, 1 April 2019

scholarly journals Does Economic Strengthening Improve Viral Suppression Among Adolescents Living with HIV? Results From a Cluster Randomized Trial in Uganda

2018 ◽  
Vol 22 (11) ◽  
pp. 3763-3772 ◽  
Author(s):  
Laura Gauer Bermudez ◽  
Fred M. Ssewamala ◽  
Torsten B. Neilands ◽  
Lily Lu ◽  
Larissa Jennings ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Viral Suppression ◽  
Cluster Randomized Trial ◽  
Cluster Randomized ◽  
Living With Hiv ◽  
Economic Strengthening

scholarly journals Acceptability and Preferences of Two Different Community Models of ART Delivery in a High Prevalence Urban Setting in Zambia: Cluster-Randomized Trial, Nested in the HPTN 071 (PopART) Study

2021 ◽  
Author(s):  
Mohammed Limbada ◽  
Chiti Bwalya ◽  
David Macleod ◽  
Osborn Shibwela ◽  
Sian Floyd ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Stated Preference ◽  
Revealed Preference ◽  
Cluster Randomized Trial ◽  
Urban Setting ◽  
People Living With Hiv ◽  
Home Based ◽  
Delivery Options ◽  
Cluster Randomized ◽  
Art Delivery

AbstractCommunity delivery of Antiretroviral therapy (ART) is a novel innovation to increase sustainable ART coverage for People living with HIV (PLHIV) in resource limited settings. Within a nested cluster-randomised sub-study in two urban communities that participated in the HPTN 071 (PopART) trial in Zambia we investigated individual acceptability and preferences for ART delivery models. Stable PLHIV were enrolled in a cluster-randomized trial of three different models of ART: Facility-based delivery (SoC), Home-based delivery (HBD) and Adherence clubs (AC). Consenting individuals were asked to express their stated preference for ART delivery options. Those assigned to the community models of ART delivery arms could choose (“revealed preference”) between the assigned arm and facility-based delivery. In total 2489 (99.6%) eligible individuals consented to the study and 95.6% chose community models of ART delivery rather than facility-based delivery when offered a choice. When asked to state their preference of model of ART delivery, 67.6% did not state a preference of one model over another, 22.8% stated a preference for HBD, 5.0% and 4.6% stated a preference for AC and SoC, respectively. Offering PLHIV choices of community models of ART delivery is feasible and acceptable with majority expressing HBD as their stated preferred option.

Sign in / Sign up

Export Citation Format

Share Document