Examining the Health Effects of NPOWER365 Among Black Same Gender Loving Men
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 350
- 主要终点
- Antiretroviral (ART) Medication Use
研究概览
简要总结
This research study aims to test the effectiveness, reach, and maintenance over time of the NPOWER365 HIV care intervention for Black men who have sex with men (BMSM) living with HIV. NPOWER365 is a BMSM community-developed multicomponent intervention that aims to: 1) Support daily health promotion via HIV health education and health maintenance reminders; 2) Foster positive social connections among BMSM via online moderated forums, interpersonal chats, and community calendars; 3) Connect clients to BMSM-affirming healthcare, including HIV treatment and mental healthcare; 4) Provide resources for housing, transportation, and other economic empowerment.
详细描述
This research study aims to test the effectiveness, reach, and maintenance over time of the NPOWER365 HIV care intervention for Black men who have sex with men (BMSM) living with HIV. NPOWER365 is a BMSM community-developed multicomponent intervention that aims to: 1) Support daily health promotion via HIV health education and health maintenance reminders; 2) Foster positive social connections among BMSM via online moderated forums, interpersonal chats, and community calendars; 3) Connect clients to BMSM-affirming healthcare, including HIV treatment and mental healthcare; 4) Provide resources for housing, transportation, and other economic empowerment.
Participants will be recruited in collaboration with NAESM INC, our community partner and the largest BMSM-led social service organization for BMSM in the Atlanta, GA metro area. We will recruit 8 participants per month. After completing an online screener to assess for basic eligibility requirements, participants will be scheduled for an online, Health Insurance Portability and Accountability Act (HIPPA)-compliant Zoom consent and baseline survey process. All online assessments will be completed using HIPAA-compliant Qualtrics surveys.
Participants will review study information and complete informed consent procedures with study staff, including agreeing to provide access to their NPOWER365 paradata (i.e., app engagement data) and HIV viral suppression results. Once consented, participants will complete a computerized timeline follow-back interview to assess HIV anti-retroviral treatment (ART) adherence and substance use, as well as measures of intersectional stigma, depressive symptoms, anxiety symptoms, emotion regulation, social support coping, ART information and motivation, and multilevel barriers to ART adherence. They will also be guided through a practice daily diary. Finally, intervention group participants will be registered for the mHealth (e.g., online forums) and institutional (e.g., linkage to care) aspects of NPOWER365(see Research Strategy of the appended NIH R01 application for additional details on these procedures). Control group participants will remain on the registration waitlist until after the 6-month study is over. All participants will receive virtual gift card compensation directly following the baseline.
All participants will complete brief daily measures of intersectional stigma, ART adherence, substance use, depressive and anxiety symptoms, emotion regulation, and social support coping for 14 days after baseline to assess NPOWER365effectiveness. Upon completion of the 2-week cycle, participants will complete a 2-week follow-up online survey, including identical measures to those received at baseline. All participants will receive compensation for their participation in the 2-week assessment as well as compensation based on the number of daily surveys they completed.
There will then be online follow-up surveys at 1-, 2-, 4-, and 6-months post baseline. These assessments will include identical measures to the baseline and 2-week assessments. As with the baseline, participants will receive virtual gift-card compensation directly after they complete their surveys. Following the 6-month assessment, all participants will participate in a second 2-week daily diary study. At the end of the 2-week process, participants will engage in a debriefing session and have the opportunity to provide feedback on the NPOWER365intervention and the research process. As with the initial daily diary period, participants will receive virtual gift-card compensation based on the number of surveys they completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Identify as Black or African American, regardless of ethnicity
- •Identify as male, regardless of sex assigned at birth
- •Are living with HIV and prescribed a daily ART regimen
- •Are age ≥ 18;
- •Have sex with men
- •Own an internet-connected device (e.g., smartphone, tablet)
- •Reside in the Atlanta-area EHE jurisdictions.
排除标准
- •Lack of English fluency
- •Past participation in the pilot.
研究组 & 干预措施
Control Arm
The 6-month waitlist control group will have access only to NAESM services not covered by NPOWER365, such as in-person events. The investigators will ensure the control group does not access the NPOWER365 mHealth app portion by screening all new app users, giving the intervention group unique private log-ins, and explaining the importance of securing those log-ins to ensure the accuracy of study results.
Intervention Arm
NPOWER365 is a multicomponent intervention that combines mHealth features and institutional to support community priorities identified in formative CBPR. In line with best practices for trials of intervention principles (TIPs) with mHealth interventions, NPOWER365 deploys intervention elements that serve to accomplish intervention strategies. NPOWER365 intervention strategies are to promote: 1)Health knowledge and motivation; 2)Social support coping; 3)Access to culturally-affirming healthcare; and 4)Housing and other economic resources. NPOWER365 pursues these strategies via these intervention elements: 1)Weekly HIV and psychological health information and motivation content and daily health notifications; 2)Online moderated forums, interpersonal chats, and community calendars; 3)Linkage to biopsychosocial healthcare via NAESM's network of Black SGLM-affirming providers; and 4)Housing and economic resources through NAESM's direct support and referral network.
干预措施: NPOWER365 HIV care intervention (Behavioral)
结局指标
主要结局
Antiretroviral (ART) Medication Use
时间窗: 24 hours
For daily surveys, participants will report ART adherence on a single binary item ("In the past 24 hours did the participant take ART medication?")
ART adherence-Long Lag Assessments
时间窗: 2 weeks
The investigators will use the NAME scale that assesses barriers to ART adherence.
次要结局
- Depressive Symptoms(24 hours)
- Anxiety Symptoms(24 hours)
- Daily Diary Substance Use(24 hours)
- Emotion Regulation-Long Lag Assessments(2 weeks)
- COPE-Long Lag Assessments(2 weeks)
- Substance Use-Long Lag Assessments(2 weeks)
- Anxiety Symptoms-Long Lag(2 weeks)
- Depressive Symptoms-Long Lag(2 weeks)
- Emotion Regulation Emotion Regulation(24 hours)
- COPE(24 hours)
研究者
Devin English, PhD
Devin English, PhD; Assistant Professor
Rutgers, The State University of New Jersey