Acceptability and Feasibility of Unsupervised HIV Self-Testing Among Networks of Men (STEP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03891407|
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : March 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections HIV/AIDS Hiv||Diagnostic Test: Self-Testing Education and Promotion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants who agree to self-test will receive pretest counseling and a 10 minute demonstration, including a video in addition to verbal instructions, of how to use an oral self-test kit from a trained HIV counselor. After counseling, participants will receive 2 oral fluid self-test kits to conduct the self-test at home or in a private location during the next 3 months, a phone number to call in case they need assistance when performing the self-test at home, and a location where to return the used self-test kits and collect more test kits throughout the study period. Upon returning the used self-test kits after every 3 months, participants will be able to share their self-test result with the counselor. Participants will also be asked at each pick-up time to demonstrate they can use the kit to ensure participants continue to receive correct self-test results throughout the study period.|
|Masking:||None (Open Label)|
|Official Title:||Acceptability and Feasibility of Unsupervised HIV Self-Testing Among Networks of Men:Tanzania STEP (Self-Testing Education and Promotion) Project|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
Experimental: HIV Self-testing Group
Camp members will receive information about HIV self-testing from peer educators who will be nominated by you and other camp members in your camp. Camp members in the STEP project will receive pretest counseling and a 10 minute demonstration. They will receive 1 oral fluid HIV self-test kit to conduct the self-test at home or in a private location during the next 1 month and a phone number to call in case you need assistance when performing the self-test at home. They will also receive information about the nearest HIV Care and Treatment Center where they can seek a confirmatory HIV test and start HIV treatment in the event of a positive self-test result.
Diagnostic Test: Self-Testing Education and Promotion
Camp members will receive the Self-Testing Education and Promotion (STEP locally referred to as Mate Yako Afya Yako) intervention and will receive HIV-counseling and oral HIV self-testing kits.
No Intervention: Non-intervention Group
Camp members will be encouraged to seek HIV testing at the clinics.
- Number of HIV self-testing kits distributed in the past 3 Months [ Time Frame: 3 months ]Camp members' use of the HIV self-testing kits will be evaluated at 3 months
- Number of camp members who self-report HIV self-testing in the past 3 months [ Time Frame: 3 months ]Camp members will self-report HIV self-testing at 3 Months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891407
|Contact: Donaldson Conserve, PhDemail@example.com|