HIV/AIDSNCT03718871
Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers
A study testing HIV testing at traditional healer practices in people with HIV/AIDS and Health Behaviors, run by Weill Medical College of Cornell University at 1 site in Uganda.
Trial summary
HIV antiretroviral therapy has the potential to dramatically decrease HIV transmission worldwide1; yet, a barrier to ending the AIDS epidemic in low-resource settings is the fact that healthcare is largely provided by traditional or spiritual healers rather than biomedical providers, and there are no strategies in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Health Behaviors
- What is being tested?
- HIV testing at traditional healer practices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUganda
- Study dates
- 1 Jul 2017to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 year of age or older
- able to provide informed consent
- not known to be HIV infected
- willing to be contacted at 3 months following enrollment
- willing to complete an exit survey after 3 months
Who cannot join
- being under the age of 18 years
- incapable of giving informed consent
- previously being diagnosed with HIV
- being unwilling to receive HIV test results
- unwilling to participate in the testing intervention
Trial locations and contacts
1 site in 1 country.
About this study
HIV antiretroviral therapy has the potential to dramatically decrease HIV transmission worldwide1; yet, a barrier to ending the AIDS epidemic in low-resource settings is the fact that healthcare is largely provided by traditional or spiritual healers rather than biomedical providers, and there are no strategies in place to identify HIV-infected patients among Traditional Healer patients and link them to HIV care. In order to reach the UNAIDS 90-90-90 benchmarks HIV services must reach marginalized populations in endemic regions, such as in southwestern Uganda. Uganda is one of seven sub-Saharan African (SSA) countries accounting for 90% of all new HIV infections in this region6. HIV prevalence is 7.3%, with ~1.5 million people living with HIV/AIDS and 99,000 new infections in 2014. However, only 50% of sexually active Ugandans have ever tested for HIV8. In the project location of southwestern Uganda, like much of SSA, the majority of Ugandans utilize Traditional Healers (TH), but little is known about Traditional Healer practices or rates of HIV testing (or HIV infection) among their clients. Specific aims of this study are to: 1) identify key socio-structural factors that frame HIV testing behaviors among Ugandan adults who utilize Traditional Healers; 2) investigate acceptability of providing point-of-care HIV testing at Traditional Healer practice locations; and 3) develop and pilot a prospective HIV testing intervention among Traditional Healer patients to promote earlier diagnosis. Results will be used to implement subsequent, large-scale cluster-randomized HIV testing intervention at Traditional Healer practice locations. Findings from the proposed study include formative data on populations that utilize Traditional Healers in an HIV-endemic region of Uganda, and pilot testing of an HIV testing intervention at healer practice locations; these results could be applied towards expanding HIV testing in other low-resource, endemic settings.
Read the detailed description
This study has three specific aims:
Specific Aim 1: Identify key socio-structural factors that frame HIV testing behaviors among clients of Ugandan TH, using an exploratory sequential, mixed-methods study design. First, qualitative interviews with 25-35 purposely-sampled TH clients will characterize the care-seeking trajectory, HIV testing behaviors and related stigma, healthcare costs, and HIV risks and exposures. Based on these results, a survey will be designed and administered to 300 Ugandan adults who utilize TH in Mbarara District. This cross-sectional study will identify 1) rates of HIV testing among TH clients and 2) variables that independently predict HIV testing within the prior 12 months. These data will inform a model of HIV testing behavior among TH clients based on the Andersen Model of Healthcare Utilization, and generate hypotheses to be tested in Specific Aim 2.
Specific Aim 2: Characterize acceptability of receiving point-of-care (POC) HIV testing at TH locations, using an exploratory sequential, mixed-methods approach. Qualitative interviews with 15-25 purposely sampled TH and 15-25 purposely-sampled TH clients will explore attitudes and experiences with biomedicine, feasibility and acceptability of delivering POC HIV testing at TH locations, and investigate relevant themes emerging from Aim 1. Based on qualitative results, a survey will be developed and administered to 175 TH in Mbarara District. This cross-sectional study will characterize TH practices relevant to HIV testing, and identify characteristics of healers who favorably view the proposed intervention (Specific Aim 3). These data will be integrated with results from SA1 to develop an intervention that will overcome socio-structural barriers to HIV testing.
Specific Aim 3: Develop and pilot an HIV testing intervention among TH clients using a cluster randomized study design. Integration of results from SA1 and SA2 will inform a pilot HIV testing intervention at 9 TH practice locations, to be compared with a control group receiving usual TH care at 8 practices. This pilot will offer HIV testing at TH practice sites to 250 TH clients at the intervention arm sites, and offer protocoled usual care to 250 clients at control arm sites. Primary outcome for this study will be rates of HIV testing among TH clients. Secondary outcomes will include i) number of new HIV diagnoses among TH clients, and ii) number of patients with +HIV POC test who successfully link to HIV care in 3 months.
- Conditions
- HIV/AIDS, Health Behaviors
- Being tested
- HIV testing at traditional healer practices
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV testing at traditional healer practicesBehavioural
HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered. Clients with positive tests will be provided with detailed contact information for the MUST ISS clinic, and given specific instructions to present to the clinic as soon as possible for confirmatory testing and linkage to care.
| Study group | Role | What they receive |
|---|---|---|
| Healer HIV testing intervention | Experimental | We will follow Ugandan National protocols to administer voluntary HIV testing at 9 TH practice locations throughout Mbarara District over a 9 month period. Receives: Behavioral: HIV testing at traditional healer practices |
| Healer control arm | No intervention | Patients will undergo protcolized usual TH care at 8 practices, which include HIV education and a referral to receive VCT through existing resources. Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of TH Clients Who Received HIV Testing
Primary study outcome was receipt of an HIV test within 90 days of enrollment. In the control arm, this was assessed via self-report at time of 90-day phone call follow up. For intervention arm, the participating healer recorded whether an HIV test was accepted by the participant at the time of the study visit. If the HIV test was accepted and delivered, the healer recorded the result of the test.
Measured: within 3 months following study visit
Secondary outcomes (5)
Number of New HIV Diagnoses Among TH Clients
For intervention arm participants, the healer recorded the result of the point-of-care HIV test for those participants who agreed to test during the study visit. In the control arm, this outcomes was assessed via self-report during the 90-day follow up phone call.
Measured: within three months following enrollment.
Number of Patients With +HIV Test Who Successfully Link to HIV Care
This outcome was assessed via self-report during the 90-day follow up phone call. For participants newly testing HIV-positive, questions were posed to determine if they had received confirmatory testing, and initiated ART medication.
Measured: at three months following enrollment.
Age in Years of Control Arm Subjects Who Received an HIV Test
Participants in the control arm assessed for primary outcomes of receiving an HIV test within 3 months of study enrollment. Participant age in years at time of study enrollment, and association with primary outcome of receiving an HIV test
Measured: 3 months following study enrollment
Gender of Control Arm Subjects Who Received an HIV Test
Self-reported participant gender and association with primary study outcome of receiving an HIV test
Measured: at 3 months following enrollment
Highest Level of Education for Control Arm Subjects Who Received an HIV Test
Participant self-reported highest level of education, and association with study primary outcome of receiving an HIV test
Measured: at 3 months following study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Jul 2017
- Primary completion1 May 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a mixed methods study where Aims 1 and 2 have both qualitative and quantitative arms. Aim 3 is an unblinded intervention, with a control arm, to be delivered in cluster-randomized fashion (Sept 2019-June 2020). Healers will be treated as clusters and randomized to either intervention or control arm.
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Radhika Sundararajan, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718871
- Sponsor's protocol ID
- 1803019105
- Other IDs
- K23MH111409
- Status last verified
- Feb 2021
- First submitted
- 21 Apr 2018
- Last updated
- 4 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified IPD may be shared with other researchers with reasonable, written requests, and approval from all researchers involved with this current study.
Publications
Sundararajan R, Ponticiello M, Lee MH, Strathdee SA, Muyindike W, Nansera D, King R, Fitzgerald D, Mwanga-Amumpaire J. Traditional healer-delivered point-of-care HIV testing versus referral to clinical facilities for adults of unknown serostatus in rural Uganda: a mixed-methods, cluster-randomised trial. Lancet Glob Health. 2021 Nov;9(11):e1579-e1588. doi: 10.1016/S2214-109X(21)00366-1.
PubMed 34678199
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers
- ClinicalTrials.gov ID
- NCT03718871
- Acronym / sponsor ID
- 1803019105
- Conditions
- HIV/AIDS, Health Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology, National Institute of Mental Health (NIMH)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Posted 4 Mar 2021
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 has the potential to dramatically decrease HIV transmission worldwide1; yet, a barrier to ending the AIDS epidemic in low-resource settings is the fact that healthcare is largely provided by traditional or spiritual healers rather than biomedical providers, and there are no strategies in place to identify HIV-infected patients among Traditional Healer patients and link them to HIV care. In order to reach the UNAIDS 90-90-90 benchmarks HIV services must reach marginalized populations in endemic regions, such as in southwestern Uganda. Uganda is one of seven sub-Saharan African (SSA) countries accounting for 90% of all new HIV infections in this region6. HIV prevalence is 7.3%, with ~1.5 million people living with HIV/AIDS and 99,000 new infections in 2014. However, only 50% of sexually active Ugandans have ever tested for HIV8. In the project location of southwestern Uganda, like much of SSA, the majority of Ugandans utilize Traditional Healers (TH), but little is known about Traditional Healer practices or rates of HIV testing (or HIV infection) among their clients. Specific aims of this study are to: 1) identify key socio-structural factors that frame HIV testing behaviors among Ugandan adults who utilize Traditional Healers; 2) investigate acceptability of providing point-of-care HIV testing at Traditional Healer practice locations; and 3) develop and pilot a prospective HIV testing intervention among Traditional Healer patients to promote earlier diagnosis. Results will be used to implement subsequent, large-scale cluster-randomized HIV testing intervention at Traditional Healer practice locations. Findings from the proposed study include formative data on populations that utilize Traditional Healers in an HIV-endemic region of Uganda, and pilot testing of an HIV testing intervention at healer practice locations; these results could be applied towards expanding HIV testing in other low-resource, endemic settings.
Detailed description
This study has three specific aims:
Specific Aim 1: Identify key socio-structural factors that frame HIV testing behaviors among clients of Ugandan TH, using an exploratory sequential, mixed-methods study design. First, qualitative interviews with 25-35 purposely-sampled TH clients will characterize the care-seeking trajectory, HIV testing behaviors and related stigma, healthcare costs, and HIV risks and exposures. Based on these results, a survey will be designed and administered to 300 Ugandan adults who utilize TH in Mbarara District. This cross-sectional study will identify 1) rates of HIV testing among TH clients and 2) variables that independently predict HIV testing within the prior 12 months. These data will inform a model of HIV testing behavior among TH clients based on the Andersen Model of Healthcare Utilization, and generate hypotheses to be tested in Specific Aim 2.
Specific Aim 2: Characterize acceptability of receiving point-of-care (POC) HIV testing at TH locations, using an exploratory sequential, mixed-methods approach. Qualitative interviews with 15-25 purposely sampled TH and 15-25 purposely-sampled TH clients will explore attitudes and experiences with biomedicine, feasibility and acceptability of delivering POC HIV testing at TH locations, and investigate relevant themes emerging from Aim 1. Based on qualitative results, a survey will be developed and administered to 175 TH in Mbarara District. This cross-sectional study will characterize TH practices relevant to HIV testing, and identify characteristics of healers who favorably view the proposed intervention (Specific Aim 3). These data will be integrated with results from SA1 to develop an intervention that will overcome socio-structural barriers to HIV testing.
Specific Aim 3: Develop and pilot an HIV testing intervention among TH clients using a cluster randomized study design. Integration of results from SA1 and SA2 will inform a pilot HIV testing intervention at 9 TH practice locations, to be compared with a control group receiving usual TH care at 8 practices. This pilot will offer HIV testing at TH practice sites to 250 TH clients at the intervention arm sites, and offer protocoled usual care to 250 clients at control arm sites. Primary outcome for this study will be rates of HIV testing among TH clients. Secondary outcomes will include i) number of new HIV diagnoses among TH clients, and ii) number of patients with +HIV POC test who successfully link to HIV care in 3 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a mixed methods study where Aims 1 and 2 have both qualitative and quantitative arms. Aim 3 is an unblinded intervention, with a control arm, to be delivered in cluster-randomized fashion (Sept 2019-June 2020). Healers will be treated as clusters and randomized to either intervention or control arm.
| Arm | Type | Receives |
|---|---|---|
| Healer HIV testing intervention | Experimental | Behavioral: HIV testing at traditional healer practicesWe will follow Ugandan National protocols to administer voluntary HIV testing at 9 TH practice locations throughout Mbarara District over a 9 month period. |
| Healer control arm | No intervention | –Patients will undergo protcolized usual TH care at 8 practices, which include HIV education and a referral to receive VCT through existing resources. Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 year of age or older
- able to provide informed consent
- not known to be HIV infected
- willing to be contacted at 3 months following enrollment
- willing to complete an exit survey after 3 months
Key exclusion criteria (5 listed)
- being under the age of 18 years
- incapable of giving informed consent
- previously being diagnosed with HIV
- being unwilling to receive HIV test results
- unwilling to participate in the testing intervention
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 |
|---|---|---|
| HIV testing at traditional healer practicesHIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered. Clients with positive tests will be provided with detailed contact information for the MUST ISS clinic, and given specific instructions to present to the clinic as soon as possible for confirmatory testing and linkage to care. | Behavioural | Healer HIV testing intervention |
Primary outcome
Number of TH Clients Who Received HIV Testing
Time frame: within 3 months following study visit
Primary study outcome was receipt of an HIV test within 90 days of enrollment. In the control arm, this was assessed via self-report at time of 90-day phone call follow up. For intervention arm, the participating healer recorded whether an HIV test was accepted by the participant at the time of the study visit. If the HIV test was accepted and delivered, the healer recorded the result of the test.
5 secondary outcomes
Number of New HIV Diagnoses Among TH Clients
Time frame: within three months following enrollment.
Number of Patients With +HIV Test Who Successfully Link to HIV Care
Time frame: at three months following enrollment.
Age in Years of Control Arm Subjects Who Received an HIV Test
Time frame: 3 months following study enrollment
Gender of Control Arm Subjects Who Received an HIV Test
Time frame: at 3 months following enrollment
Highest Level of Education for Control Arm Subjects Who Received an HIV Test
Time frame: at 3 months following study enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34678199Sundararajan R, Ponticiello M, Lee MH, Strathdee SA, Muyindike W, Nansera D, King R, Fitzgerald D, Mwanga-Amumpaire J. Traditional healer-delivered point-of-care HIV testing versus referral to clinical facilities for adults of unknown serostatus in rural Uganda: a mixed-methods, cluster-randomised trial. Lancet Glob Health. 2021 Nov;9(11):e1579-e1588. doi: 10.1016/S2214-109X(21)00366-1.
- Individual participant dataSharing planned: Undecided. De-identified IPD may be shared with other researchers with reasonable, written requests, and approval from all researchers involved with this current study.
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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, MD, PhD 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 HIV testing at traditional healer practices in people with HIV/AIDS and Health Behaviors, run by Weill Medical College of Cornell University at 1 site in Uganda.
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 5 inclusion and 5 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 4 Mar 2021. 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 Uganda. 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?
Yes. Results are posted in the registry (first posted 4 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of TH Clients Who Received HIV Testing (time frame: within 3 months following study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03718871, which also lists 1 linked publication.
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 4 Mar 2021.