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Completed

NCT Number: NCT04071873

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

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.

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Key information

Conditions

HIV Behavior Health Behavior

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute for Medical Research

Mwanza, Tanzania

About this study

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..

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Point-of-care HIV testing

Diagnostic Test

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.

HIV testing education

Behavioral

Participants will be provided with education on community based HIV resources.

Primary outcomes

  1. Rate of HIV testing

    Time frame: Within 3 months following visit

    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.

Secondary outcomes

  1. Rate of new HIV diagnosis

    Time frame: 3 months

    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.

Other outcomes

  1. Linkage to HIV care at 3 months post enrollment

    Time frame: 3 months

    Rate of successful care linkage for participants with a new HIV diagnosis who received point-of-care HIV testing as compared to participants who received education regarding community HIV resources.Linkage to care will be defined as accessing outpatient care or treatment such as antiretroviral therapy (ART).

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute for Medical Research, Tanzania

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2019
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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