Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23MH111409 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Mbarara University of Science and Technology | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV testing at traditional healer practices | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 3 months following study visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within three months following enrollment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Radhika Sundararajan, MD, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mbarara University of Science and Technology | Mbarara | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34678199 | Derived | 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. |
Not provided
Not provided
De-identified IPD may be shared with other researchers with reasonable, written requests, and approval from all researchers involved with this current study.
Not provided
Not provided
Not provided
Not provided
Five healers were excluded due to self-reported weekly volume <7 patients. Three healers declined to participate because of scheduling conflicts. On August 2, 2019 the remaining 17 healers were randomized into two study arms (9 to intervention, 8 to control. From August 8, 2019-February 7, 2020, 500 participants were enrolled at healer cluster sites
25 traditional healers practicing within an eight-kilometer distance from Mbarara Township were screened for eligibility.
| ID | Title | Description |
|---|---|---|
| FG000 | Healer Control Arm | Patients will undergo protocolized usual care at 8 healer practices, which includes HIV education and a referral to receive voluntary HIV testing at local medical clinics. |
| FG001 | Healer HIV Testing Intervention | 9 healers will deliver pre-test counseling and offer HIV 1/2 antigen-antibody POC test (Oraquick©) to eligible participants. Post-test counseling will be delivered and those testing positive will be provided information about where to receive linkage to HIV care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healer Control Arm | Patients will undergo protcolized usual care at 8 healer practices, which include HIV education and a referral to receive VCT through local HIV testing clinics. Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | within 3 months following study visit |
|
Three months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healer Control Arm | Patients will undergo protcolized usual care at 8 healer practices, which include HIV education and a referral to receive VCT through local HIV testing clinics. Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT. |
Not provided
Not provided
Our goal was to evaluate the effectiveness of delivering HIV testing via a novel implementation strategy. This was not a large-scale cost-effectiveness trial. Future studies are needed to evaluate program cost. Since we excluded healers with the lowest patient volume, results may not be generalizable to these smaller practices.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Radhika Sundararajan | Weill Cornell Medicine | (646) 962-4654 | ras9199@med.cornell.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2018 | Dec 31, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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 | 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 | 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 | at 3 months following study enrollment |
| Healer HIV Testing Intervention |
HIV testing at traditional healer practices: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Number of participants who completed primary education or lower | Count of Participants | Participants |
|
| Number of participants who are Christian | Count of Participants | Participants |
|
| Number of participants who are married | Count of Participants | Participants |
|
| Healer HIV Testing Intervention |
HIV testing at traditional healer practices: 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. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | within three months following enrollment. |
|
|
|
|
| Secondary | 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. | Zero participants in the control arm were newly diagnosed with HIV infection. | Posted | Count of Participants | Participants | at three months following enrollment. |
|
|
|
|
| Secondary | 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 | Only control arm participants who received an HIV test were included in this analysis, as all intervention arm participants accepted an HIV test as part of the study and therefore, no other variates would be statistically associated with receiving a test more than being in the intervention study arm. | Posted | Median | Inter-Quartile Range | years | 3 months following study enrollment |
|
|
|
|
| Secondary | 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 | Participants in the control arm assessed for primary outcomes of receiving an HIV test within 3 months of study enrollment. Only control arm participants were included in this analysis, as all intervention arm participants accepted an HIV test as part of the study and therefore, no other variates would be statistically associated with receiving a test more than being in the intervention study arm. | Posted | Count of Participants | Participants | at 3 months following enrollment |
|
|
|
|
| Secondary | 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 | We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects. | Posted | Count of Participants | Participants | at 3 months following study enrollment |
|
|
|
|
| 0 |
| 250 |
| 0 |
| 250 |
| 0 |
| 250 |
| EG001 | Healer HIV Testing Intervention | HIV testing at traditional healer practices: 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. | 0 | 250 | 0 | 250 | 0 | 250 |
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
No comparison between study arm groups was made in this analysis, as it was limited to control arm only. |
No comparison was made with the intervention arm