Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Columbia University | OTHER |
| Ministry of Health and Social Services, Namibia | OTHER_GOV |
| Kenya Ministry of Health | OTHER_GOV |
| Ministry of Health, Tanzania |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparison | No Intervention | ||
| HIV prevention intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV prevention intervention | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unprotected vaginal and anal sex | Baseline | |
| Unprotected vaginal and anal sex | 6 month follow-up | |
| Unprotected vaginal and anal sex | 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of sex partners | Baseline | |
| Number of sex partners | 6 month follow-up | |
| Number of sex partners |
Not provided
Inclusion Criteria:
Kenya: English, Kiswahili Namibia: English, Oshiwambo, Damara-nama, Otjiherero, Afrikaans Tanzania: English, Kiswahili
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pamela Bachanas, PhD | Centers for Disease Control and Prevention | Principal Investigator |
| Daniel Kidder, PhD | Centers for Disease Control and Prevention | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23459196 | Derived | 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. |
Not provided
Not provided
Not provided
| OTHER_GOV |
| Ministry of Health and Social Welfare, Zanzibar | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 month follow-up |
| Number of sex partners getting an HIV test | Baseline |
| Number of sex partners getting an HIV test | 6 month follow-up |
| Number of sex partners getting an HIV test | 12 month follow-up |
| Disclosure of HIV status to sex partners | Baseline |
| Disclosure of HIV status to sex partners | 6 month follow-up |
| Disclosure of HIV status to sex partners | 12-month follow-up |
| Alcohol use | Baseline |
| Alcohol use | 6 month follow-up |
| Alcohol use | 12-month follow-up |
| Adherence to HIV antiretroviral medications | Baseline |
| Adherence to HIV antiretroviral medications | 6 month follow-up |
| Adherence to HIV antiretroviral medications | 12-month follow-up |
| Unintended pregnancy or partner pregnancy | Baseline |
| Unintended pregnancy or partner pregnancy | 6 month follow-up |
| Unintended pregnancy or partner pregnancy | 12-month follow-up |
| Provision of family planning counseling and services | Baseline |
| Provision of family planning counseling and services | 6 month follow-up |
| Provision of family planning counseling and services | 12-month follow-up |