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临床试验/NCT04108078
NCT04108078已完成不适用

Multi-Level Intervention Addressing Intersectional Stigma to Improve HIV Testing in MSM

Yale University1 个研究点 分布在 1 个国家目标入组 549 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
549
试验地点
1
主要终点
HIV testing frequency (for MSM)

研究概览

简要总结

HIV prevalence among men with have sex with men (MSM) in Ghana is at least eight times higher than that of the general population (2%). MSM in Ghana face high levels of stigma due to HIV status (actual or perceived), same-sex behavior, and gender non-conformity. These stigmas are documented barriers to HIV prevention and treatment. In our preliminary work in Ghana (N=137), one-third of MSM had never been tested for HIV. This study is a randomized controlled trial to evaluate the feasibility, acceptability and estimate effect size of a multi-component, multi-level (organizational, interpersonal, and intrapersonal-level) intersectional stigma-reduction intervention to increase HIV testing frequency among MSM in Ghana where HIV, same-sex behavior and gender non-conformity are highly stigmatized. To date, stigma-reduction interventions in Ghana have focused on uni-level targets (e.g., health care facilities (HCFs)) and addressed one type of stigma (e.g., HIV), without engaging the intersectional character of the multiple stigmas that MSM encounter.

Our specific aims are:

  1. to evaluate the feasibility and acceptability of a novel multi-component, multi-level intervention to address intersectional stigma.
  2. to estimate effect size of the intervention for scale up to a definitive efficacy trial.

Our primary endpoint are:

For MSM: HIV testing, intervention feasibility and acceptability For HCFs: intervention feasibility, acceptability and appropriateness

Our secondary endpoints are:

MSM: Intersectional stigma reduction HCF: Intersectional stigma reduction

This study will combine three theory-based interventions that were previously implemented separately in Ghana for reducing stigma at HCF-level, increasing HIV testing at the peer group-level, and increasing peer social support at the individual-level. Convergence Framework will be used for combining interventions. The ADAPT-ITT framework guides our approach to enhancing the interventions' content on intersectional stigma. To achieve these aims a systematic adaptation that will be used to refine the individually developed HCF, peer- and individual-level interventions to produce a comprehensive multi-level intersectional stigma reduction intervention.

详细描述

STUDY DESCRIPTION OVERVIEW. Our goal in this study is to determine the feasibility, acceptability and preliminary estimate of effect size of a multi- level intersectional stigma-reduction intervention on HIV testing among MSM in Ghana. This study has two phases: a formative phase and a test phase. The eight-step ADAPT-ITT framework will guide our approach to enhancing the interventions' content to address intersectional stigma and combine the three separate interventions into one multi- level approach. Aim 1 will encompass steps 1-7, leading to the combined multi-level intervention adapted to deepen intersectional stigma content and step 8 in which the study team will conduct a waitlist-controlled RCT of the adapted intervention for feasibility and acceptability. In Aim 2, data generated in the RCT will be used to estimate the effect size of the multi-level intervention on HIV testing among MSM (primary outcome) and intersectional stigma reduction (secondary outcome) among the MSM and HCF staff. In deciding on the RCT with wait-list control was considered with other designs such as factorial designs and a classic RCT design with time and attention-matched controls. It was determined that the RCT with wait-list control was superior to the other designs because our study is premised on the need for combined interventions. Since it is not intended yet to seek to isolate which component of the intervention had the greatest effect on our outcomes, a factorial design was not scientifically justified for our proposed study. Additionally, ethical and budgetary considerations informed our decision to forgo using a structurally equivalent control in favor of a wait-list control for the intervention given the evidence of each interventions' efficacy for reducing stigma among HCF staff and improving HIV testing among MSM.

FORMATIVE PHASE STEP 1: ASSESS Focus group discussions (FGDs) and in-depth interviews (IDIs) will be conducted with MSM and HCF staff to inform the adaptation of the three existing interventions to deepen intersectional stigma content and their integration with each other to address intersectional stigma at multiple levels. FGDs were chosen because of their demonstrated suitability in studies of sexual health and to capitalize on the spontaneous conversational interaction that occurs in groups. This re-creation of the social dynamic with the HCF staff and MSM is critical to the understanding of intersectional stigma from the social organization of these two groups. There are also plans to conduct a limited set of individual interviews to examine more in-depth, topics that elicit intimate personal accounts that may not be suitable for sharing in groups. For example, MSM PLHIV are targeted for IDIs to gain insight into whether and how intersectional stigma experiences influenced their pre- diagnosis prevention behaviors, access to prevention services, timing of HIV testing and linkage to care post-diagnosis.

Qualitatively, the following will be investigated:

  1. the drivers and manifestations of HIV, same-sex and gender non-conforming stigmas (intersectional stigma) within HCFs and MSM peer groups
  2. how these intersecting stigmas undermine HIV testing
  3. perspectives on strategies for reducing intersectional stigma within HCFs and among MSM peer groups. This information will guide to what degree and how these stigmas are addressed within the intervention.

In each study city (Accra and Kumasi), 2-4 FGDs will take place in each with HCF staff and MSM, as well as IDIs with HP+ trainers from the pilot phase (n=10) and MSM with HIV (n=8). The purpose and expectations of involvement in the study will be explained to prospective participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •***RCT***
  • •Inclusion Criteria:
  • •For the RCT, HCF staff are eligible to participate in the study if they are:
  • •* Employed at one of the eight facilities identified for this study and identified with a potential to encounter MSM clients.
  • •For the RCT, MSM are eligible to participate in the study if they are:
  • •Biologically male at birth
  • •Currently self-identify as cisgender man
  • •Report sexual activity with another man at least once within the previous six months and report that they are HIV-negative or status unknown.

排除标准

  • •HCF staff will be excluded if they anticipate leaving work at the HCF during the study period or have previously participated in HP.
  • •MSM will be excluded if they plan to move out of the area during the study period.
  • •***Focus Group Discussions (FGDs)***
  • •Inclusion Criteria:
  • •HCF staff are eligible to participate in the FGDs if they are:
  • •* Employed at a study participating facility.
  • •MSM are eligible to participate in FGDs if they are:
  • •18 years or older
  • •Biologically male at birth
  • •Currently self-identified as cisgender man
  • •Reported sex with another man at least once within the previous six months. Note: HIV status is not an inclusion criterion for MSM FGD participation.
  • •***In-Depth Interviews (IDI)***
  • •HCF staff are eligible to participate if they are:
  • •Trained in Health Policy Plus (HP+)
  • •Have previously delivered HP+ in a Ghanaian HCF
  • •MSM are eligible to participate if:
  • •18 years or older
  • •Biologically male at birth
  • •Currently self-identified as cisgender man
  • •Reported sex with another man at least once within the previous six months
  • •Self-reported that they are living with HIV
  • •Exclusion Criteria:
  • •* Those who do not meet the inclusion criteria listed above

研究组 & 干预措施

Intervention

Experimental

This arm consists of 1) MSM who receive the intervention (not wait listed) and healthcare facility staff who work at health facilities that have been chosen for the intervention.

干预措施: Health Policy Plus (HP+) (Behavioral)

Intervention

Experimental

This arm consists of 1) MSM who receive the intervention (not wait listed) and healthcare facility staff who work at health facilities that have been chosen for the intervention.

干预措施: Many Men Many Voices (3MV) (Behavioral)

Intervention

Experimental

This arm consists of 1) MSM who receive the intervention (not wait listed) and healthcare facility staff who work at health facilities that have been chosen for the intervention.

干预措施: HIV Education, Empathy and Empowerment (HIVE3) (Behavioral)

Wait listed

No Intervention

Participants in this arm (MSM and staff at health facilities that were wait listed) will complete assessments, but will receive the intervention after the experimental arm of the study.

结局指标

主要结局

HIV testing frequency (for MSM)

时间窗: Change from baseline at 6 months post- intervention

The intervention will be assessed in the number of completed HIV tests at 6 months compared to baseline. We will combine non-duplicative numbers of self-report and clinic-verified HIV tests (verification is only if an MSM had an HIV test performed at one of the healthcare facilities participating in the multi-level intervention) we are only measuring this outcome with MSM.

HIV testing frequency (for MSM)

时间窗: Change from baseline at 3 months post- intervention

The intervention will be assessed in the number of completed HIV tests at 3 months compared to baseline. We will combine non-duplicative numbers of self-report and clinic-verified HIV tests (verification is only if an MSM had an HIV test performed at one of the healthcare facilities participating in the multi-level intervention) we are only measuring this outcome with MSM.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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