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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01256463
Enrollment
3548
Registered
2010-12-08
Start date
2009-10-31
Completion date
2013-01-31
Last updated
2017-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

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.

Interventions

Sponsors

Columbia University
CollaboratorOTHER
Ministry of Health and Social Services, Namibia
CollaboratorOTHER_GOV
Kenya Ministry of Health
CollaboratorOTHER_GOV
Ministry of Health, Tanzania
CollaboratorOTHER_GOV
Ministry of Health and Social Welfare, Zanzibar
CollaboratorOTHER_GOV
Centers for Disease Control and Prevention
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Unprotected vaginal and anal sexBaseline

Secondary

MeasureTime frame
Number of sex partners getting an HIV testBaseline
Disclosure of HIV status to sex partnersBaseline
Alcohol useBaseline
Number of sex partnersBaseline
Unintended pregnancy or partner pregnancyBaseline
Provision of family planning counseling and servicesBaseline
Adherence to HIV antiretroviral medicationsBaseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026