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临床试验/NCT01256463
NCT01256463
已完成
不适用

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

Centers for Disease Control and Prevention0 个研究点目标入组 3,548 人2009年10月
适应症HIV

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
HIV
发起方
Centers for Disease Control and Prevention
入组人数
3548
主要终点
Unprotected vaginal and anal sex
状态
已完成
最后更新
9年前

概览

简要总结

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.

注册库
clinicaltrials.gov
开始日期
2009年10月
结束日期
2013年1月
最后更新
9年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Daniel Kidder

Health Scientist

Centers for Disease Control and Prevention

入排标准

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Unprotected vaginal and anal sex

时间窗: 12-month follow-up

次要结局

  • Unintended pregnancy or partner pregnancy(12-month follow-up)
  • Number of sex partners getting an HIV test(12 month follow-up)
  • Disclosure of HIV status to sex partners(12-month follow-up)
  • Alcohol use(12-month follow-up)
  • Provision of family planning counseling and services(12-month follow-up)
  • Adherence to HIV antiretroviral medications(12-month follow-up)
  • Number of sex partners(12 month follow-up)

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