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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256463
• Other study ID #: CDC-CGH-5540
• Status: Completed
• Phase: N/A
• First received: December 7, 2010
• Last updated: December 30, 2016
• Start date: October 2009
• Est. completion date: January 2013

Study information

• Verified date: December 2016
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3548
• Est. completion date: January 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• HIV prevention intervention

Locations

Country	Name	City	State
n/a

Sponsors (6)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unprotected vaginal and anal sex		Baseline	No
Primary	Unprotected vaginal and anal sex		6 month follow-up	No
Primary	Unprotected vaginal and anal sex		12-month follow-up	No
Secondary	Number of sex partners		Baseline	No
Secondary	Number of sex partners		6 month follow-up	No
Secondary	Number of sex partners		12 month follow-up	No
Secondary	Number of sex partners getting an HIV test		Baseline	No
Secondary	Number of sex partners getting an HIV test		6 month follow-up	No
Secondary	Number of sex partners getting an HIV test		12 month follow-up	No
Secondary	Disclosure of HIV status to sex partners		Baseline	No
Secondary	Disclosure of HIV status to sex partners		6 month follow-up	No
Secondary	Disclosure of HIV status to sex partners		12-month follow-up	No
Secondary	Alcohol use		Baseline	No
Secondary	Alcohol use		6 month follow-up	No
Secondary	Alcohol use		12-month follow-up	No
Secondary	Adherence to HIV antiretroviral medications		Baseline	No
Secondary	Adherence to HIV antiretroviral medications		6 month follow-up	No
Secondary	Adherence to HIV antiretroviral medications		12-month follow-up	No
Secondary	Unintended pregnancy or partner pregnancy		Baseline	No
Secondary	Unintended pregnancy or partner pregnancy		6 month follow-up	No
Secondary	Unintended pregnancy or partner pregnancy		12-month follow-up	No
Secondary	Provision of family planning counseling and services		Baseline	No
Secondary	Provision of family planning counseling and services		6 month follow-up	No
Secondary	Provision of family planning counseling and services		12-month follow-up	No