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Completed

NCT Number: NCT01256463

HIV Prevention for PLHIV: Evaluation of an Intervention Toolkit for HIV Care & Treatment Settings

The rapid scale-up of HIV care and treatment in resource-limited settings provides the opportunity to reach many HIV-positive individuals with prevention messages and interventions in care and treatment settings. However, HIV prevention is rarely incorporated into the routine care and treatment of people living with HIV, leaving missed opportunities to reach patients with critical interventions.

This study will evaluate an HIV prevention intervention package for health care settings in sub-Saharan Africa. The HIV prevention intervention will be delivered to HIV-seropositive patients in HIV care and treatment clinics during all routine visits. Health care providers (HCPs) will deliver HIV prevention messages on correct and consistent condom use, disclosure of serostatus, partner HIV testing, adherence and alcohol reduction. They will also assess and treat sexually transmitted infections (STIs) and provide basic contraceptives and safer pregnancy counseling.

Trained lay counselors (LCs) will deliver HIV prevention interventions in the clinics. LCs will be persons without medical training, many of whom will be PLHIV, who will be trained to provide HIV prevention counseling, promote HIV testing of partners and children (and provide HIV testing where allowed by national guidelines), and counsel HIV-positive patients on medication adherence and alcohol use.

The prevention intervention package will be evaluated in HIV clinics in three sub-Saharan African countries: Kenya, Namibia, and Tanzania. This project will be a longitudinal group-randomized trial with 9 intervention clinics (3 per country) and 9 comparison clinics (3 per country). Two hundred patients per clinic (total N = 3600) will be followed for 12 months. This evaluation will examine the effectiveness of the HIV prevention interventions delivered by HCPs and LCs on patient-level outcomes such as risky sexual behavior, disclosure of HIV status, partner HIV testing, alcohol use, HIV antiretroviral (ARV) medication adherence, STI treatment, pregnancies, and contraceptive use.

In addition to the patient outcomes, the acceptability of the interventions and materials, as well as the feasibility of integrating the interventions into HIV care and treatment settings, will be assessed.

Data will be collected via patient interviews, HCP and LC questionnaires, observations of HCP and LC patient visits, patient medical chart review, and review of clinic service data.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • At least 18 years old
  • HIV-positive patients receiving care at a project clinic and seen at the clinic at least twice prior to enrollment
  • Sexually active within the past three months
  • Planning to attend the clinic for at least 1 year
  • Able to conduct interview in one of the following languages:

Kenya: English, Kiswahili Namibia: English, Oshiwambo, Damara-nama, Otjiherero, Afrikaans Tanzania: English, Kiswahili

  • Able to provide informed consent to participate in the project

Exclusion criteria

  • Younger than 18 years of age
  • Not sexually active within the last three months
  • Planning to move from the vicinity of the clinic within one year
  • Not enrolled in the HIV clinic and/or have not been seen for at least two clinic visits
  • Cannot provide informed consent
  • Patients who are acutely ill or are determined by clinical staff to be too ill to participate
  • Spouses or identified partners of participating patients
  • Pregnant women and male partners of pregnant women, as family planning counseling and unintended pregnancy are some of the primary study outcomes
  • Not able to complete interview in one of the languages in the inclusion criteria
  • Participated in pilot study

Treatment and study plan

HIV prevention intervention

Behavioral

Primary outcomes

  1. Unprotected vaginal and anal sex

    Time frame: Baseline

  2. Unprotected vaginal and anal sex

    Time frame: 6 month follow-up

  3. Unprotected vaginal and anal sex

    Time frame: 12-month follow-up

Secondary outcomes

  1. Number of sex partners

    Time frame: Baseline

  2. Number of sex partners

    Time frame: 6 month follow-up

  3. Number of sex partners

    Time frame: 12 month follow-up

  4. Number of sex partners getting an HIV test

    Time frame: Baseline

  5. Number of sex partners getting an HIV test

    Time frame: 6 month follow-up

  6. Number of sex partners getting an HIV test

    Time frame: 12 month follow-up

  7. Disclosure of HIV status to sex partners

    Time frame: Baseline

  8. Disclosure of HIV status to sex partners

    Time frame: 6 month follow-up

  9. Disclosure of HIV status to sex partners

    Time frame: 12-month follow-up

  10. Alcohol use

    Time frame: Baseline

  11. Alcohol use

    Time frame: 6 month follow-up

  12. Alcohol use

    Time frame: 12-month follow-up

  13. Adherence to HIV antiretroviral medications

    Time frame: Baseline

  14. Adherence to HIV antiretroviral medications

    Time frame: 6 month follow-up

  15. Adherence to HIV antiretroviral medications

    Time frame: 12-month follow-up

  16. Unintended pregnancy or partner pregnancy

    Time frame: Baseline

  17. Unintended pregnancy or partner pregnancy

    Time frame: 6 month follow-up

  18. Unintended pregnancy or partner pregnancy

    Time frame: 12-month follow-up

  19. Provision of family planning counseling and services

    Time frame: Baseline

  20. Provision of family planning counseling and services

    Time frame: 6 month follow-up

  21. Provision of family planning counseling and services

    Time frame: 12-month follow-up

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • Columbia University
  • Kenya Ministry of Health
  • Ministry of Health and Social Services, Namibia
  • Ministry of Health and Social Welfare, Zanzibar
  • Ministry of Health, Tanzania

Registry information

Official study title

HIV Prevention for People Living With HIV/AIDS: Evaluation of an Intervention Toolkit for HIV Care and Treatment Settings

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Dec 8, 2010
Registry last updated
Jan 2, 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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