Comprehensive Triaged HIV Prevention in Tanzania

Study Overview
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Brief Summary
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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.

Official Title
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Phase II RCT of Comprehensive Triaged HIV Prevention: Tanzania

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Comprehensive Triaged HIV Prevention (CTHP)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTHP<br>HIV Voluntary Counseling and Testing at Community Prevention Center-The center will be open to all community members. Community Mobilization-HIV/AIDS and VCT information will be disseminated with pamphlets, community discussions, and meetings. Risk Assessment and Triaged Counseling and Recruitment-Clients identified at high-risk for HIV infection and HIV-infected clients we be offered an additional counseling session. Participation will be incentivized. These clients will also be provided with up to 3 referral cards to give to sexual partners. If partners come for VCT, they will receive a small incentive. Incentives & Support Activities - Modest and ethically appropriate incentives, including those providing nutritional support (food), health and hygiene benefits (bed nets), transport to access interventions, or income generation potential, will be provided for participation in some project interventions, and these will be graduated based on HIV risk potential. | Behavioral: Comprehensive Triaged HIV Prevention (CTHP)<br>* HIV Voluntary Counseling and Testing at Community Prevention Center-The center will be open to all community members. Community Mobilization-HIV/AIDS and VCT information will be disseminated with pamphlets, community discussions, and meetings. Risk Assessment and Triaged Counseling and Recruitment-Clients identified at high-risk for HIV infection and HIV-infected clients we be offered an additional counseling session. Participation will be incentivized. These clients will also be provided with up to 3 referral cards to give to sexual partners. If partners come for VCT, they will receive a small incentive. Incentives & Support Activities - Modest and ethically appropriate incentives, including those providing nutritional support (food), health and hygiene benefits (bed nets), transport to access interventions, or income generation potential, will be provided for participation in some project interventions, and these will be graduated based on HIV risk potential.<br>|
| No Intervention: Standard of Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STI Incidence | Incidence of sexually transmitted infections (STI) defined as any incident case of syphilis, HIV, or herpes simplex virus-2. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and acceptability | 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. | 18 months (during intervention) | 
| Sexual risk behavior | 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. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV prevention, Behavioral intervention, Community-randomized trial