Status-neutral Community-based Multilevel Intervention to Address Intersectional Stigma and Discrimination, and Increase HIV Testing, PrEP, and ART Uptake Among YGBMSM in Ghanaian Slums: A Clustered Randomized Control Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 880
- 试验地点
- 1
- 主要终点
- Change in HIV testing.
研究概览
简要总结
The primary objective of this study is to adapt and evaluate the feasibility of "Lafiya," which means "Wellness" in Hausa, a multilevel intersectional stigma & discrimination (ISD) and HIV testing intervention, to a status-neutral intervention to increase HIV testing, PrEP, and ART Uptake (HPART) among young gay, bisexual, and other men who have sex with men in Ghanaian slums. Specific objectives include, Assessing intersectional stigma and options for HPART implementation, Adapting Lafiya to a status-neutral intervention to address intersectional stigma and increase HPART uptake among YGBMSM, Test acceptance, feasibility, appropriateness, and preliminary efficacy of Lafiya to address intersectional stigma and increase HIVST uptake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •YGBMSM FGD and IDI: To be eligible for FGD, the person must be between 18 to 25 years old, currently identify as a cis-gender man, have had sex with another man within 8 months before engaging with the recruitment team, and must reside within a slum community in the Accra metropolitan areas. To be eligible for IDIs, participants must self-disclose living with HIV.
- •GBMSM civil society organizations FGD: The person must have experience providing GBMSM with HIV prevention and care services for at least one year. Must reside in the Accra metropolitan area.
- •HCF staff FGDs: HCF staff are eligible to participate in the FGDs if employed at a study-participating facility.
- •Anti-ISD Trained Nurses IDIs HCF staff are eligible to participate if they are trained in our previous interventions and have previously delivered them in a Ghanaian HCF.
排除标准
- •YGBMSM FGD and IDI: Persons outside the age range of 18 to 25 years old, persons who do not identify as cis-gender men, persons who have not had sex with another man within 8 months before engaging with the recruitment team.
- •GBMSM civil society organizations FGD: persons who do not have experience providing GBMSM with HIV prevention and care services for at least one year. Persons who do not reside within a slum community in the Accra metropolitan area (residence outside this area would be excluded).
- •HCF staff FGDs: HCF staff are not eligible to participate in the FGDs if they are not employed at a study-participating facility.
- •Anti-ISD Trained Nurses IDIs: HCF staff are not eligible to participate if they are not trained in our previous interventions and have not previously delivered them in a Ghanaian HCF.
研究组 & 干预措施
Intervention Arm
Participants will be young gay, bisexual and all other men who have sex men (YGBMSM) and providers from healthcare institutions working with (YGBMSM) who will receive the LAFIYA intervention.
干预措施: LAFIYA (Behavioral)
Waitlist control group.
Control arm for comparison who will receive the intervention after the intervention group
干预措施: LAFIYA (Behavioral)
结局指标
主要结局
Change in HIV testing.
时间窗: Baseline to 9 months
We are going to collect the total number of HIV tests performed by all participants and report the mean change in numbers.
Change in PrEP Adherence.
时间窗: Baseline to 9 months
We will collect the total number of PrEP uptake and report the mean change in adherence ( mean change in urine tenofovir levels).
Change in ART Adherence
时间窗: Baseline to 9 months
We will assess changes in ART adherence among participants receiving HIV treatment, reporting mean changes in ART adherence (measured by HIV RNA levels).
Change in Treatment Self-Efficacy.
时间窗: Baseline to 9 months
We will assess changes in treatment self-efficacy among participants receiving HIV treatment, reporting mean changes in treatment self-efficacy scores. The scale will inquire into the experiences of treatment-related behaviors related to adhering to treatment plans, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage change of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated for an overall percentage.
次要结局
- Percentage of participants that reported Brief Resilience(Baseline to 9 months)
- Neighborhood stigma(Baseline to 9 months)
- Mean change in the Basic Needs Satisfaction(Baseline to 9 months)
- Percentage change in HIV stigmatizing attitudes.(Baseline to 9 months)
- Percentage change in gender nonconformity stigma(Baseline to 9 months)
- Percentage of participants that reported healthcare climate stigma.(Baseline to 9 months)
- Changes in Healthcare facility Intersectional stigma and discrimination.(Baseline to 9 months)
- Percentage change in reported sexual behavior stigma.(Baseline to 9 months)
- Percentage change in PrEP-related stigma(Baseline to 9 months)
研究者
Gamji Rabiu Abu-Ba'are
Assistant professor
University of Rochester