Implementation of Rapid HIV Self-Testing Among MSM Project
- Conditions
- HIV/AIDS
- Interventions
- Behavioral: Know@HomeOther: Self-test Kit
- Registration Number
- NCT04219878
- Lead Sponsor
- Emory University
- Brief Summary
This study will use online materials and strategies to recruit 3600 Black and Hispanic men who have sex with men (MSM) and transgender women (TGW) to participate in a study evaluating the effectiveness of the Know@Home mobile app compared to control condition with respect to linkage of participants to appropriate services, as well as cost-effectiveness outcomes.
- Detailed Description
To evaluate the effectiveness of mailing out rapid HIV home-testing kits and additional testing promotion components among African-American or black and Hispanic or Latino gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW), the study "Implementation of Rapid HIV Self-Testing among MSM Project", known as iSTAMP, is being conducted in 11 US states. This study is interested in the most cost-effective ways to recruit people at high risk for HIV infection. The researchers want to study a sample of 3600 adult MSM and TGW who are not known to be living with HIV; 1800 black/African-American and 1800 Hispanic/Latino participants will be enrolled.
All participants will be mailed two rapid HIV self-test kits upon randomization. All participants, regardless of study arm, will also complete a follow-up survey at the end of a 4-month follow-up period. At the end of the 4-month follow-up period, participants will be mailed a dried blood spot (DBS) collection kit for research purposes, as well as another rapid HIV self-test kit for immediate testing. Participants in each of the arms will have access to videoconferencing-delivered prevention counseling, and all participants, regardless of assigned arm, will be contacted if they report seroconversion and/or a preliminary positive test during the study period for active linkage to care.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 2195
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Know@Home App or Website and Test Kit Know@Home Participants in this study arm will have access to Know@Home, a mobile HIV prevention app or website and will receive mail-out HIV self-testing kits. Know@Home App or Website and Test Kit Self-test Kit Participants in this study arm will have access to Know@Home, a mobile HIV prevention app or website and will receive mail-out HIV self-testing kits. Mail-Out Testing Kit Only Self-test Kit Participants in this study arm will receive mail-out HIV self-testing kits.
- Primary Outcome Measures
Name Time Method Number of participants initiating HIV treatment Up to Month 4 Effectiveness of the interventions will be assessed by linkage of participants to HIV treatment.
Cost of different online venues for HIV test results returned Month 1 The cost (in US dollars) of HIV tests returned within 1 month of enrollment will be compared between the study arms. The costs involved with having HIV tests returned include:
* Online banner advertisement placement
* Study staff time managing enrollment, validating participant eligibility, monitoring and evaluation of enrollment data
* HIV test kits
* Shipping for HIV test kits
* Staff/personnel time to manage mailing/return of test kits
* Other general and administrative time, office supplies, equipment, rents, utilitiesCost of different online venues for identifying new HIV diagnoses Month 1 The cost (in US dollars) of identifying established HIV infections will be compared between the study arms. The costs involved with identifying established HIV infections include:
* Online banner advertisement placement
* Study staff time managing enrollment, validating participant eligibility, monitoring and evaluation of enrollment data
* HIV test kits
* Shipping for HIV test kits
* Staff/personnel time to manage mailing/return of test kits
* Study staff time to manage monitoring and evaluation of HIV test result data
* Study staff time to provide phone counseling to those with established infections
* Other general and administrative time, office supplies, equipment, rents, utilitiesCost of different online venues for study enrollment Baseline Enrollment in the study defined as completion of the baseline survey and downloading of the study app. The cost (in US dollars) to enroll participants (online banner advertisement placement, study staff time to manage enrollment, validating participant eligibility, monitoring and evaluation of enrollment data) will be compared between the study arms.
Number of participants initiating PrEP treatment Up to Month 4 Effectiveness of the interventions will be assessed by linkage of participants to PrEP treatment.
Number of participants testing for STIs Up to Month 4 Effectiveness of the interventions will be assessed by linkage of participants to STI testing.
Number of participants engaging in HIV prevention services Up to Month 4 Effectiveness of the interventions will be assessed by linkage of participants to HIV prevention services.
Number of participants engaging in HIV social services Up to Month 4 Effectiveness of the interventions will be assessed by linkage of participants to HIV social services.
- Secondary Outcome Measures
Name Time Method Cost of linkage to HIV counseling Month 4 The cost (in US dollars) of linking participants testing positive for HIV to HIV counseling will be compared between the study arms, including:
* Study staff time spent contacting participants
* Study staff time for intervention maintenance (e.g., app management)
* HIV counseling costs to the healthcare system
* Other general and administrative time, office supplies, equipment, rents, utilitiesCost of linkage to STI treatment Month 4 The cost (in US dollars) of providing treatment for STIs discovered through at-home STI testing be compared between the three study arms, including:
* Study staff time processing orders and contacting participants
* Study staff time for intervention maintenance (e.g., app management)
* STI treatment costs to the healthcare system
* Other general and administrative time, office supplies, equipment, rents, utilitiesCost of linkage to PrEP uptake Month 4 The cost (in US dollars) of linking participants testing negative for HIV to initiate PrEP treatment will be compared between the study arms, including:
* Study staff time contacting participants
* Study staff time for intervention maintenance (e.g., app management)
* PrEP uptake costs to the healthcare system
* Other general and administrative time, office supplies, equipment, rents, utilitiesCost of linkage to PrEP counseling Month 4 The cost (in US dollars) of linking participants testing negative for HIV to PrEP counseling will be compared between the study arms, including:
* Study staff time contacting participants
* Study staff time for intervention maintenance (e.g., app management)
* PrEP counseling costs to the healthcare system
* Other general and administrative time, office supplies, equipment, rents, utilitiesCost of Sexually Transmitted Infection (STI) testing Month 4 The cost (in US dollars) of providing at-home STI testing be compared between the study arms, including:
* Cost of STI testing materials and shipping
* Laboratory STI testing
* Study staff time processing orders and contacting participants
* Study staff time for intervention maintenance (e.g., app management)
* STI testing costs to the healthcare system
* Other general and administrative time, office supplies, equipment, rents, utilitiesCost of linkage to HIV treatment Month 4 The cost (in US dollars) of linking participants testing positive for HIV to HIV treatment will be compared between the three study arms, including:
* Study staff time for intervention maintenance (e.g., app management)
* HIV treatment costs to the healthcare system
* Other general and administrative time, office supplies, equipment, rents, utilities
Trial Locations
- Locations (1)
Emory University
🇺🇸Atlanta, Georgia, United States