Comprehensive Triaged HIV Prevention in Tanzania

NCT02018978 | Completed Phase 2

• 1 other identifier: R01MH095869
• Study Type: interventional
• Target: 739
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

HIV prevention; Behavioral intervention; Community-randomized trial

Outcome Measures

Primary Outcomes (1)

• STI Incidence

  Incidence of sexually transmitted infections (STI) defined as any incident case of syphilis, HIV, or herpes simplex virus-2.

  18 months

Secondary Outcomes (2)

• Safety and acceptability

  18 months (during intervention)

• Sexual risk behavior

  18 months

Study Arms (2)

CTHP

EXPERIMENTAL

1. HIV Voluntary Counseling and Testing at Community Prevention Center-The center will be open to all community members. 2. Community Mobilization-HIV/AIDS and VCT information will be disseminated with pamphlets, community discussions, and meetings. 3. 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. 4. 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)

Standard of Care

NO INTERVENTION

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.

Interventions

Comprehensive Triaged HIV Prevention (CTHP) BEHAVIORAL

1. HIV Voluntary Counseling and Testing at Community Prevention Center-The center will be open to all community members. 2. Community Mobilization-HIV/AIDS and VCT information will be disseminated with pamphlets, community discussions, and meetings. 3. 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. 4. 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.

CTHP

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Muhimbili University of Health and Allied Sciences: collaborator

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Location

Study Officials

• Michael D Sweat, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 24, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

TA (1)