HIVNCT04071873
A Novel Approach to Community-based HIV Testing With Traditional Healers in Mwanza, Tanzania
A study testing Point-of-care HIV testing and HIV testing education in people with HIV and Health Behavior, run by Weill Medical College of Cornell University at 1 site in Tanzania.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Health Behavior
- What is being tested?
- Point-of-care HIV testing and HIV testing education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTanzania
- Study dates
- 14 Oct 2019to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Inclusion specific to point-of-care HIV testing intervention:
- Willing to have point of care HIV test
- Willing to receive results of HIV test
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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..
- Conditions
- HIV, Health Behavior
- Being tested
- Point-of-care HIV testing, HIV testing education
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care HIV testingDiagnostic 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 educationBehavioural
Participants will be provided with education on community based HIV resources.
| Study group | Role | What they receive |
|---|---|---|
| Point-of-care HIV testing (intervention) | Experimental | Participants will be offered voluntary point-of-care HIV testing during a traditional healer visit. Receives: Diagnostic Test: Point-of-care HIV testing |
| Education on community HIV resources (control) | Active comparator | Participants will be offered education regarding HIV testing and community resources during a traditional healer visit. Receives: Behavioral: HIV testing education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 months following visit
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start14 Oct 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania
- Responsible party
- Sponsor
- Investigators
- Radhika Sundararajan, PhD, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071873
- Sponsor's protocol ID
- 19-04020274
- Status last verified
- Oct 2020
- First submitted
- 26 Aug 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Community-based HIV Testing With Traditional Healers in Mwanza, Tanzania
- ClinicalTrials.gov ID
- NCT04071873
- Acronym / sponsor ID
- 19-04020274
- Conditions
- HIV, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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..
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Point-of-care HIV testing (intervention) | Experimental | Diagnostic Test: Point-of-care HIV testingParticipants will be offered voluntary point-of-care HIV testing during a traditional healer visit. |
| Education on community HIV resources (control) | Active comparator | Behavioral: HIV testing educationParticipants will be offered education regarding HIV testing and community resources during a traditional healer visit. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- less than 18 years of age
- Known to be HIV-infected
- Unable to provide informed consent
- Unwilling to participate in follow-up
- Unwilling to have point-of-care HIV test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care HIV testingParticipants 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. | Diagnostic test | Point-of-care HIV testing (intervention) |
| HIV testing educationParticipants will be provided with education on community based HIV resources. | Behavioural | Education on community HIV resources (control) |
Primary outcome
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.
1 secondary outcome
Rate of new HIV diagnosis
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be made available.
Related trials for HIV
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
Active, not recruitingPhase 2
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
HIV, Heavy Drinking
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
Active, not recruitingPhase 2
A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)
HIV Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radhika Sundararajan, PhD, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care HIV testing and HIV testing education in people with HIV and Health Behavior, run by Weill Medical College of Cornell University at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of HIV testing (time frame: Within 3 months following visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.