Clinical trial NCT01256463: HIV Prevention for PLHIV: Evaluation of an Intervention Toolkit for HIV Care & Treatment Settings
Official title: HIV Prevention for People Living With HIV/AIDS: Evaluation of an Intervention Toolkit for HIV Care and Treatment Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Columbia University
name: Ministry of Health and Social Services, Namibia
name: Kenya Ministry of Health
name: Ministry of Health, Tanzania
name: Ministry of Health and Social Welfare, Zanzibar
First posted: 2010-12-08
Enrollment: 3548
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Unprotected vaginal and anal sex
timeFrame: Baseline
measure: Unprotected vaginal and anal sex
timeFrame: 6 month follow-up
measure: Unprotected vaginal and anal sex
timeFrame: 12-month follow-up
Secondary outcomes:
measure: Number of sex partners
timeFrame: Baseline
measure: Number of sex partners
timeFrame: 6 month follow-up
measure: Number of sex partners
timeFrame: 12 month follow-up
measure: Number of sex partners getting an HIV test
timeFrame: Baseline
measure: Number of sex partners getting an HIV test
timeFrame: 6 month follow-up
measure: Number of sex partners getting an HIV test
timeFrame: 12 month follow-up
measure: Disclosure of HIV status to sex partners
timeFrame: Baseline
measure: Disclosure of HIV status to sex partners
timeFrame: 6 month follow-up
measure: Disclosure of HIV status to sex partners
timeFrame: 12-month follow-up
measure: Alcohol use
timeFrame: Baseline
measure: Alcohol use
timeFrame: 6 month follow-up
measure: Alcohol use
timeFrame: 12-month follow-up
measure: Adherence to HIV antiretroviral medications
timeFrame: Baseline
measure: Adherence to HIV antiretroviral medications
timeFrame: 6 month follow-up
measure: Adherence to HIV antiretroviral medications
timeFrame: 12-month follow-up
measure: Unintended pregnancy or partner pregnancy
timeFrame: Baseline
measure: Unintended pregnancy or partner pregnancy
timeFrame: 6 month follow-up
measure: Unintended pregnancy or partner pregnancy
timeFrame: 12-month follow-up
measure: Provision of family planning counseling and services
timeFrame: Baseline
measure: Provision of family planning counseling and services
timeFrame: 6 month follow-up
measure: Provision of family planning counseling and services
timeFrame: 12-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Pamela Bachanas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Daniel Kidder, PhD
role: STUDY_DIRECTOR
References:
citation: Kidder DP, Bachanas P, Medley A, Pals S, Nuwagaba-Biribonwoha H, Ackers M, Howard A, Deluca N, Mbatia R, Sheriff M, Arthur G, Katuta F, Cherutich P, Somi G; PwP Evaluation Study team. HIV prevention in care and treatment settings: baseline risk behaviors among HIV patients in Kenya, Namibia, and Tanzania. PLoS One. 2013;8(2):e57215. doi: 10.1371/journal.pone.0057215. Epub 2013 Feb 25.