Comprehensive Triaged HIV Prevention in Tanzania

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Medical University of South Carolina
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
Michael Sweat, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT02018978
First received: December 17, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
HIV
Behavioral: Comprehensive Triaged HIV Prevention (CTHP)
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 710
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CTHP
  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)
  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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018978

Locations
Tanzania
Muhimbili University of Health and Allied Sciences Recruiting
Dar es Salaam, Tanzania
Contact: Jessie Mwambo, MD    +2550784339747    jmwambo@gmail.com   
Sub-Investigator: Jessie Mbwambo, MD         
Sponsors and Collaborators
Medical University of South Carolina
Muhimbili University of Health and Allied Sciences
Investigators
Principal Investigator: Michael D Sweat, PhD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Michael Sweat, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02018978     History of Changes
Other Study ID Numbers: R01MH095869
Study First Received: December 17, 2013
Last Updated: December 17, 2013
Health Authority: United States: Federal Government
Tanzania: National Institute for Medical Research

Keywords provided by Medical University of South Carolina:
HIV prevention
Behavioral intervention
Community-randomized trial

ClinicalTrials.gov processed this record on August 26, 2014