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Completed

NCT Number: NCT02018978

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.

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Key information

Conditions

HIV

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Comprehensive Triaged HIV Prevention (CTHP)

Behavioral
  • 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.

Primary outcomes

  1. STI Incidence

    Time frame: 18 months

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

Secondary outcomes

  1. Safety and acceptability

    Time frame: 18 months (during intervention)

    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.

  2. Sexual risk behavior

    Time frame: 18 months

    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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences

Registry information

Official study title

Phase II RCT of Comprehensive Triaged HIV Prevention: Tanzania

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 24, 2013
Registry last updated
Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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