Overview

This trial is active, not recruiting.

Condition hiv
Treatment hiv prevention intervention
Sponsor Centers for Disease Control and Prevention
Collaborator Columbia University
Start date October 2009
End date December 2011
Trial size 3548 participants
Trial identifier NCT01256463, CDC-CGH-5540

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
(Experimental)
The HIV prevention intervention will be delivered to HIV-seropositive patients in HIV care and treatment clinics during all routine visits. Health care providers (including physicians, clinical officers, and nurses) will deliver HIV prevention messages on correct and consistent condom use, disclosure of serostatus, partner HIV testing, adherence and alcohol reduction during clinic visits. Health care providers will also assess and treat sexually transmitted infections (STIs), and provide basic contraceptives and brief safer pregnancy counseling.
hiv prevention intervention

Primary Outcomes

Measure
Unprotected vaginal and anal sex
time frame: Baseline
Unprotected vaginal and anal sex
time frame: 6 month follow-up
Unprotected vaginal and anal sex
time frame: 12-month follow-up

Secondary Outcomes

Measure
Number of sex partners
time frame: Baseline
Number of sex partners
time frame: 6 month follow-up
Number of sex partners
time frame: 12 month follow-up
Number of sex partners getting an HIV test
time frame: Baseline
Number of sex partners getting an HIV test
time frame: 6 month follow-up
Number of sex partners getting an HIV test
time frame: 12 month follow-up
Disclosure of HIV status to sex partners
time frame: Baseline
Disclosure of HIV status to sex partners
time frame: 6 month follow-up
Disclosure of HIV status to sex partners
time frame: 12-month follow-up
Alcohol use
time frame: Baseline
Alcohol use
time frame: 6 month follow-up
Alcohol use
time frame: 12-month follow-up
Adherence to HIV antiretroviral medications
time frame: Baseline
Adherence to HIV antiretroviral medications
time frame: 6 month follow-up
Adherence to HIV antiretroviral medications
time frame: 12-month follow-up
Unintended pregnancy or partner pregnancy
time frame: Baseline
Unintended pregnancy or partner pregnancy
time frame: 6 month follow-up
Unintended pregnancy or partner pregnancy
time frame: 12-month follow-up
Provision of family planning counseling and services
time frame: Baseline
Provision of family planning counseling and services
time frame: 6 month follow-up
Provision of family planning counseling and services
time frame: 12-month follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title HIV Prevention for People Living With HIV/AIDS: Evaluation of an Intervention Toolkit for HIV Care and Treatment Settings
Principal investigator Pamela Bachanas, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Centers for Disease Control and Prevention.