A Novel Approach to Community-based HIV Testing With Traditional Healers in Mwanza, Tanzania

Study Overview
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Brief Summary
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HIV antiretroviral therapy (ART) has the potential to dramatically decrease HIV transmission worldwide. In Tanzania, HIV prevalence is  5%, with 1.6 million people living with HIV/AIDS; it is the leading cause of hospitalization and death among Tanzanian adults. However, less than 50% of HIV-infected Tanzanian adults know their status.Successful implementation of community-based services requires an understanding of the social and cultural context that influence community engagement with HIV services. Specifically, many HIV endemic regions are also medically pluralistic communities, where multiple explanatory frameworks for health and disease co-exist. In these areas, HIV testing and ART clinical care do not occur in isolation; traditional healers are commonly utilized instead of or concurrently with biomedical services. Therefore, the success of decentralized, community-based HIV services must be founded upon a thorough understanding of medical pluralism, and engagement with traditional healers as stakeholders in community health. This study will investigate the feasibility of involving traditional healers in HIV testing, and pilot an intervention to expand HIV testing within communities that use traditional medicine in Mwanza, Tanzania.

Detailed Description
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This study has two specific aims. Specific Aim 1: Tailor a point of care HIV testing intervention for delivery in northwestern Tanzania, using data from 1) qualitative interviews and 2) community engagement strategies. Interviews with traditional healers, traditional and biomedical clients, and HIV clinic staff will illustrate local variables impacting HIV testing engagement. A community advisory board with stakeholder members will guide program implementation, tailoring protocols to maximize uptake. Specific Aim 2: Conduct a cluster-randomized pilot of the HIV testing intervention. This pilot will offer HIV testing at five traditional healer practice sites, compared with a control group of five healers providing education on community HIV resources..

Official Title
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A Novel Approach to Community-based HIV Testing With Traditional Healers in Mwanza, Tanzania

Conditions
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HIV, Health Behavior

Intervention / Treatment
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* Diagnostic Test: Point-of-care HIV testing
* Behavioral: HIV testing education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Not known to be HIV-infected Client of a traditional healer practice Willing to be contacted for monthly follow-up for three months Willing to complete an exit survey at the end of three months Able to provide informed consent Inclusion specific to point-of-care HIV testing intervention: Willing to have point of care HIV test Willing to receive results of HIV test Exclusion Criteria: less than 18 years of age Known to be HIV-infected Unable to provide informed consent Unwilling to participate in follow-up Exclusion specific to point-of-care HIV testing intervention: Unwilling to have point-of-care HIV test Unwilling to receive the results of HIV test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Point-of-care HIV testing (intervention)<br>Participants will be offered voluntary point-of-care HIV testing during a traditional healer visit. | Diagnostic Test: Point-of-care HIV testing<br>* Participants will undergo an HIV 1/2 antibody point of care test (Oraquick) and receive pre- and post-test counselling.Participants with positive tests will be referred to the HIV clinic for Western Blot confirmation, and linkage to care.<br>|
| Active Comparator: Education on community HIV resources (control)<br>Participants will be offered education regarding HIV testing and community resources during a traditional healer visit. | Behavioral: HIV testing education<br>* Participants will be provided with education on community based HIV resources.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of HIV testing | Rate of HIV testing among clients of traditional healers who were offered point-of-care HIV testing, as compared to clients who were offered education regarding community HIV resources. | Within 3 months following visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of new HIV diagnosis | Rate of new HIV diagnosis among clients of traditional healers who were offered point-of-care HIV testing, as compared to clients who were offered education regarding community HIV resources. | 3 months |