Comprehensive Triaged HIV Prevention in Tanzania
This is a 3-year Phase II trial of a HIV prevention strategy designed to significantly reduce population-level HIV incidence. The study design is a two-arm community randomized controlled trial of Comprehensive Triaged HIV Prevention (CTHP) which includes: (a) Access to an HIV center which will provide free HIV testing and counseling, (b) Educational activities related to HIV risk behavior, (c) Special counseling sessions for HIV-infected clients, (d) A onetime provision of a small amount of food or health products for sex partners of persons testing positive for HIV or reporting HIV risk behaviors when they come to receive HIV testing, (e) A post test support club for persons infected with HIV, (f) An income generation training program for people testing positive for HIV, (g) Transportation assistance in visiting the HIV Care and Treatment Clinic in the area for those who test positive for HIV, and, (h) Counseling and transportation support for those on medical treatment for HIV to assist them in attending scheduled appointments, and receiving and taking their medications as recommended by the clinic staff. The study will take place within two communities located in Kisarawe district, Tanzania. The intervention will occur over an 18-month period with outcomes assessed at baseline and post-intervention. The study hypothesis is that individuals in the intervention community will have a lower incidence of sexually transmitted infections (STIs) than those in the control community.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase II RCT of Comprehensive Triaged HIV Prevention: Tanzania|
- STI Incidence [ Time Frame: 18 months ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02018978
|Muhimbili University of Health and Allied Sciences|
|Dar es Salaam, Tanzania|
|Principal Investigator:||Michael D Sweat, PhD||Medical University of South Carolina|