Comprehensive Triaged HIV Prevention in Tanzania
This trial is active, not recruiting.
|Treatment||comprehensive triaged hiv prevention (cthp)|
|Sponsor||Medical University of South Carolina|
|Collaborator||Muhimbili University of Health and Allied Sciences|
|Start date||October 2013|
|End date||March 2016|
|Trial size||739 participants|
|Trial identifier||NCT02018978, R01MH095869|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
time frame: 18 months
Safety and acceptability
time frame: 18 months (during intervention)
Sexual risk behavior
time frame: 18 months
Male or female participants from 18 years up to 55 years old.
Inclusion Criteria: - Be between 18-55 years of age - Lives in the household regularly - Able to provide informed consent - Plans on living in the study area for the duration of the study (2 years) Exclusion Criteria: - Younger than 18 years of age or older than 55 years of age - Does not reside in the household regularly - Is not able to provide informed consent - Does not plan on living in the study area for study duration (2 years)
|Official title||Phase II RCT of Comprehensive Triaged HIV Prevention: Tanzania|
|Principal investigator||Michael D Sweat, PhD|
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