Comprehensive Triaged HIV Prevention in Tanzania
|ClinicalTrials.gov Identifier: NCT02018978|
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : October 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Comprehensive Triaged HIV Prevention (CTHP)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||739 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II RCT of Comprehensive Triaged HIV Prevention: Tanzania|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Behavioral: Comprehensive Triaged HIV Prevention (CTHP)
No Intervention: Standard of Care
This arm will receive standard of care HIV-related services, including clinic-based voluntary counseling and testing and referrals to HIV care and treatment government-run facilities.
- STI Incidence [ Time Frame: 18 months ]Incidence of sexually transmitted infections (STI) defined as any incident case of syphilis, HIV, or herpes simplex virus-2.
- Safety and acceptability [ Time Frame: 18 months (during intervention) ]Safety and acceptability of the intervention will be assessed through weekly reports detailing any adverse social or physical events related to participation in the intervention compiled by study staff.
- Sexual risk behavior [ Time Frame: 18 months ]Sexual risk behavior will be measured by assessing condom use at last sex with each sexual partner, frequency of condom use in the last 6 months with each sexual partner, and number of sexual partners in the last 6 months.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018978
|Muhimbili University of Health and Allied Sciences|
|Dar es Salaam, Tanzania|
|Principal Investigator:||Michael D Sweat, PhD||Medical University of South Carolina|