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| Name | Class |
|---|---|
| Emory University | OTHER |
| BroadReach Healthcare | INDUSTRY |
| United States Agency for International Development (USAID) | FED |
| Mpumalanga Department of Health |
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Many South African men do not visit clinics or get tested due to multiple real and perceived barriers. Nkangala District has significant gaps to identifying PLHIV who are not on ART, reaching their ART targets, especially in adult men. Over 65% of PLHIV not on ART are men, which is a gap of over 39,000 men living with HIV needing to be tested and initiated on ART.
Study Objectives: BroadReach in collaboration with UCLA, UCT and Nkangala DOH will pilot test an innovative index partner HIVSS strategy in one urban and one rural clinic to evaluate acceptability, barriers, and efficacy of secondary HIVSS distribution in a randomized control trial enrolling women newly diagnosed with HIV or on ART.
Study design: Randomized control trial of n=180 WLHIV (90 in each arm) in four facilities (urban and rural) in the Nkangala district ensure that the results are generalizable.
Many South African men do not visit clinics or get tested due to multiple real and perceived barriers. Nkangala District has significant gaps to identifying PLHIV who are not on ART, reaching their ART targets, especially in adult men. Over 65% of PLHIV not on ART are men, which is a gap of over 39,000 men living with HIV needing to be tested and initiated on ART.
We will partner with BroadReach Healthcare, a PEPFAR partner in South Africa, to pilot test an innovative index partner HIVSS strategy in one urban and one rural public health clinic in the Nkangala district of Mpumalanga Province to evaluate acceptability, barriers, and preliminary efficacy of secondary HIVSS distribution in a randomized control trial enrolling women newly diagnosed with HIV or on ART. In the intervention arm, women will receive counselling on how to use HIVSS, how to encourage their male partner to screen, and 2 HIVSSs with HIVSS instructions and invitation to return for confirmatory testing. In the standard of care arm, index women will receive counselling on the importance of disclosure to their family and partner(s) and referral for HIV testing (per SA national guidelines). We will evaluate the following aims:
Conduct a mixed-methods survey with N=180 HIV+ women to assess perceived acceptability and barriers (including perceived safety, IPV) to secondary HIVSS distribution by women to male partners.
Test the feasibility and preliminary efficacy of secondary HIVSS distribution through a 1:1 randomized control trial in n=180 HIV+ women to assess, comparing standard of care to intervention arm:
i. Measured via options of: index or partner self-report, SMS/WhatsApp of a picture of the used HIVSS sent by partner or index, return of a used self-test to the facility by either the index or partner, and/or partner coming into facility for with an invitation for confirmatory testing or SOC counseling referral c. % of male partners with a positive HIV screening/test result d. % of newly diagnosed male partners who initiate ART within 3 months of diagnosis e. % of those on ART with viral suppression after 6 months on ART (index and partners)
In the intervention arm, we will assess acceptability and barriers (including safety/IPV) related to HIVSS distribution or use via surveys with all intervention participants who return for the study endline survey and a convenience samples of n=20 male partners (n=10 men who used HIVSS and n=10 men who did not use HIVSS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV self testing | Experimental | HIV+ women will receive HIV self-tests (2) to bring home to her partner to offer for testing |
|
| Standard of care | Active Comparator | In the standard of care arm, women will receive standard of care partner referrals for HIV testing, including counselling about disclosure and referral for her partner(s) to return to the facility for testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV self test | Diagnostic Test | For women allocated to the intervention arm, the participant will be given HIV self testing and counseling on their use & importance of partner testing, to take home to their partner(s). |
| Measure | Description | Time Frame |
|---|---|---|
| Partner HIV Testing | proportion of index partners who report testing | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Positivity | Proportion of male partners tested who test HIV+ | 3 months |
| ART Initiation | Proportion of male partners tested who initiate antiretroviral therapy (ART) |
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Inclusion Criteria:
Exclusion Criteria:
Failure to meet all of inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Wall, PhD | Emory University | Principal Investigator |
| Kathryn Dovel, PhD | University of California, Los Angeles | Study Director |
| Dhirisha Naidoo | BroadReach Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Health Clinics | Nkangala | Mpumalanga | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35690880 | Derived | Joseph Davey DL, Wall KM, Naidoo N, Naidoo D, Xaba G, Serao C, Malone T, Dovel K. HIV testing and linkage to ART following secondary distribution of HIV self-test kits to male partners of women living with HIV: a pilot randomized control trial in Mpumalanga, South Africa. J Int AIDS Soc. 2022 Jun;25(6):e25937. doi: 10.1002/jia2.25937. |
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Will be made available upon request to study team
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| ID | Title | Description |
|---|---|---|
| FG000 | HIV Self Testing | HIV+ women will receive HIV self-tests (2) to bring home to her partner to offer for testing HIV self test: For women allocated to the intervention arm, the participant will be given HIV self testing and counseling on their use & importance of partner testing, to take home to their partner(s). Counseling and referral for partner testing: Counseling and refer participant's partner for facility based HIV testing |
| FG001 | Standard of Care | In the standard of care arm, women will receive standard of care partner referrals for HIV testing, including counselling about disclosure and referral for her partner(s) to return to the facility for testing. Counseling and referral for partner testing: Counseling and refer participant's partner for facility based HIV testing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HIV Self Testing | HIV+ women will receive HIV self-tests (2) to bring home to her partner to offer for testing HIV self test: For women allocated to the intervention arm, the participant will be given HIV self testing and counseling on their use & importance of partner testing, to take home to their partner(s). Counseling and referral for partner testing: Counseling and refer participant's partner for facility based HIV testing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Partner HIV Testing | proportion of index partners who report testing | Posted | Count of Participants | Participants | 3 months |
|
From baseline to endline in the study (3 months)
Any medical, social adverse event per DAIDS criteria
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HIV Self Testing | HIV+ women will receive HIV self-tests (2) to bring home to her partner to offer for testing HIV self test: For women allocated to the intervention arm, the participant will be given HIV self testing and counseling on their use & importance of partner testing, to take home to their partner(s). Counseling and referral for partner testing: Counseling and refer participant's partner for facility based HIV testing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dvora Joseph Davey | UCLA | 310-701-1526 | dvoradavey@ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 20, 2020 | Jun 2, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| OTHER_GOV |
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|
| Counseling and referral for partner testing | Behavioral | Counseling and refer participant's partner for facility based HIV testing |
|
| 3 months |
| Viral Suppression | Proportion of male partners and index partners who achieve viral suppression | 3 months |
| BG001 | Standard of Care | In the standard of care arm, women will receive standard of care partner referrals for HIV testing, including counselling about disclosure and referral for her partner(s) to return to the facility for testing. Counseling and referral for partner testing: Counseling and refer participant's partner for facility based HIV testing |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Positivity | Proportion of male partners tested who test HIV+ | Posted | Count of Participants | Participants | 3 months |
|
|
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| Secondary | ART Initiation | Proportion of male partners tested who initiate antiretroviral therapy (ART) | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Viral Suppression | Proportion of male partners and index partners who achieve viral suppression | Not Posted | 3 months | Participants |
| 0 |
| 86 |
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | Standard of Care | In the standard of care arm, women will receive standard of care partner referrals for HIV testing, including counselling about disclosure and referral for her partner(s) to return to the facility for testing. Counseling and referral for partner testing: Counseling and refer participant's partner for facility based HIV testing | 0 | 91 | 0 | 91 | 0 | 91 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D005159 | Health Care Facilities Workforce and Services |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |