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

This study has been completed.
Sponsor:
Collaborators:
Columbia University
Namibia Ministry of Health and Social Services
Kenya Ministry of Health
Ministry of Health, Tanzania
Ministry of Health and Social Welfare, Zanzibar
Information provided by (Responsible Party):
Daniel Kidder, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01256463
First received: December 7, 2010
Last updated: December 30, 2016
Last verified: December 2016
  Purpose

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.


Condition Intervention
HIV
Behavioral: HIV prevention intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HIV Prevention for People Living With HIV/AIDS: Evaluation of an Intervention Toolkit for HIV Care and Treatment Settings

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 3548
Study Start Date: October 2009
Study Completion Date: January 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Comparison
Experimental: HIV prevention intervention
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.
Behavioral: HIV prevention intervention

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256463

Sponsors and Collaborators
Centers for Disease Control and Prevention
Columbia University
Namibia Ministry of Health and Social Services
Kenya Ministry of Health
Ministry of Health, Tanzania
Ministry of Health and Social Welfare, Zanzibar
Investigators
Principal Investigator: Pamela Bachanas, PhD Centers for Disease Control and Prevention
Study Director: Daniel Kidder, PhD Centers for Disease Control and Prevention
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Kidder, Health Scientist, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01256463     History of Changes
Other Study ID Numbers: CDC-CGH-5540
Study First Received: December 7, 2010
Last Updated: December 30, 2016

ClinicalTrials.gov processed this record on March 27, 2017