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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04071873
• Other study ID #: 19-04020274
• Status: Completed
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2020
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior
• HIV

Intervention

Diagnostic Test:
• Point-of-care HIV testing
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.

Behavioral:
• HIV testing education
Participants will be provided with education on community based HIV resources.

Locations

Country	Name	City	State
Tanzania	National Institute for Medical Research	Mwanza

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute for Medical Research, Tanzania

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Linkage to HIV care at 3 months post enrollment	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).	3 months
Primary	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	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