Getting to Zero Among Highest HIV Incidence (HHI) Men Who Have Sex With Men (MSM) in the American South: Testing an Integrated Strategy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 2,700
- 试验地点
- 1
- 主要终点
- To evaluate whether the HPTN 096 integrated strategy increases the number of HHI MSM clients at PHASE healthcare facilities.
研究概览
简要总结
This study will evaluate a status-neutral integrated strategy to improve access to and uptake of HIV prevention and treatment services for the highest HIV incidence (HHI) men who have sex with men (MSM) in participating communities. The ultimate goal is to establish a strategy to reduce HIV incidence among HHI MSM in the southern United States (US) by increasing the number of HHI MSM accessing prevention and treatment services, increasing uptake and use of pre-exposure prophylaxis (PrEP) among those living without HIV and increasing retention in care, and thus viral suppression, among those living with HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Cross-Sectional HHI MSM Client Assessment Inclusion Criteria
- •At least 18 years of age
- •Self-reports a lifetime history of anal sex with another man (i.e., at any time in their life)
- •Determined to be HHI within the study community per Centers for Disease Control and Prevention surveillance data
- •Willing and able to provide consent to participate in the study
- •Have a medical visit scheduled during the designated sampling period at a PHASE treatment or prevention healthcare facility
- •Cross-Sectional HHI MSM Client Assessment
排除标准
- •Individuals who have any condition that, in the opinion of the Investigator of Record (IoR) or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives, will be excluded from the cross-sectional assessment.
- •There are no co-enrollment restrictions for participation in this assessment.
- •----------------------------------------
- •HHI MSM Clients In-depth Interviews (IDIs) Inclusion Criteria
- •Met inclusion criteria for the cross-sectional HHI MSM client assessment
- •Completed the cross-sectional HHI MSM client assessment
- •Willing and able to provide assent/consent
- •HHI MSM Clients IDIs Exclusion Criteria
- •Individuals who have any condition that, in the opinion of the Investigator of Record (IoR) or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives, will be excluded from the qualitative interview.
- •There are no co-enrollment restrictions for these interviews.
- •----------------------------------------
- •PHASE HCF Staff IDIs Inclusion Criteria
- •Is a staff member at a participating PHASE facility
- •Participated in at least one PHASE activity (e.g., attended a PHASE Foundation training, participated in Extension of Community Healthcare Outcomes training, member of PHASE quality improvement team)
- •Willing and able to provide consent
- •PHASE HCF Staff IDIs Exclusion Criteria
- •Individuals who have any condition that, in the opinion of the Investigator of Record (IoR) or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives, will be excluded from the qualitative interview.
- •There are no co-enrollment restrictions for these interviews
- •----------------------------------------
研究组 & 干预措施
Integrated Strategy
HPTN 096 is a hybrid implementation-efficacy trial that uses a single arm interrupted time series (ITS) design to test whether a status-neutral integrated strategy improves access to and uptake of HIV prevention and treatment services for HHI MSM. ITS measures a change in slope for the primary outcomes pre- and post-intervention using four one-year look backs of EMR data. The integrated strategy will be delivered in up to five selected communities in the southern US.
干预措施: Health Access Coalitions (Behavioral)
Integrated Strategy
HPTN 096 is a hybrid implementation-efficacy trial that uses a single arm interrupted time series (ITS) design to test whether a status-neutral integrated strategy improves access to and uptake of HIV prevention and treatment services for HHI MSM. ITS measures a change in slope for the primary outcomes pre- and post-intervention using four one-year look backs of EMR data. The integrated strategy will be delivered in up to five selected communities in the southern US.
干预措施: Social Media (Behavioral)
Integrated Strategy
HPTN 096 is a hybrid implementation-efficacy trial that uses a single arm interrupted time series (ITS) design to test whether a status-neutral integrated strategy improves access to and uptake of HIV prevention and treatment services for HHI MSM. ITS measures a change in slope for the primary outcomes pre- and post-intervention using four one-year look backs of EMR data. The integrated strategy will be delivered in up to five selected communities in the southern US.
干预措施: Peer Support (Behavioral)
Integrated Strategy
HPTN 096 is a hybrid implementation-efficacy trial that uses a single arm interrupted time series (ITS) design to test whether a status-neutral integrated strategy improves access to and uptake of HIV prevention and treatment services for HHI MSM. ITS measures a change in slope for the primary outcomes pre- and post-intervention using four one-year look backs of EMR data. The integrated strategy will be delivered in up to five selected communities in the southern US.
干预措施: Promoting Human Autonomy Support & Empathy (PHASE) (Behavioral)
结局指标
主要结局
To evaluate whether the HPTN 096 integrated strategy increases the number of HHI MSM clients at PHASE healthcare facilities.
时间窗: Month 12
Number of HHI MSM with a visit at the HCF in the previous 12 months (Source: EMR).
To evaluate whether the HPTN 096 integrated strategy increases retention in care among HHI MSM living with HIV at PHASE healthcare facilities.
时间窗: Month 12
Number of HHI MSM living with HIV with at least two HIV medical visits to the HCF at least 90 days apart within the previous 12 months (Source: EMR)
To evaluate whether the HPTN 096 integrated strategy increases PrEP prescriptions for HHI MSM not living with HIV at PHASE healthcare facilities.
时间窗: Month 12
Any PrEP prescription among all HHI MSM without HIV with a medical visit at the HCF within the previous 12 months (Source: EMR).
次要结局
- To evaluate whether the HPTN 096 integrated strategy increases viral suppression (<200 copies/mL) in HHI MSM living with HIV at PHASE healthcare facilities.(Month 12)
- To evaluate whether the HPTN 096 integrated strategy increases PrEP initiation, adherence and persistence for HHI MSM not living with HIV at PHASE healthcare facilities.(Months 4, 15, 27)
- To evaluate whether the HPTN 096 integrated strategy increases PrEP initiation, adherence and persistence for HHI MSM not living with HIV at PHASE healthcare facilities.(Month 12)
- To assess changes in the experience of autonomy support among HHI MSM at PHASE healthcare facilities.(Months 4, 15, 27)
- To assess changes in the experience of autonomy support among HHI MSM at PHASE healthcare facilities.(Month 17 and 27)
- To assess how autonomy support, social support, stigma, barriers to healthcare and individual agency among HHI MSM at PHASE healthcare facilities are associated with engagement in care (including PrEP prescription and viral suppression).(Months 4, 15, 27)