Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners
NCT ID: NCT03271307
Last Updated: 2020-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
6369 participants
INTERVENTIONAL
2017-09-25
2019-01-25
Brief Summary
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Aim 1 will be a cluster-randomized trial in 15 clusters (high-burden health facilities) in Malawi. We will enroll 6,000 adult OPD clients (15 years or older) to test the feasibility and cost-effectiveness of facility-based HIV self-testing (HIVST) for OPD clients.
Aim 2 will be an individually-randomized trial in 3 high-burden health facilities in Malawi. We will enroll 500 adult HIV-positive clients (15 years or older) to test the feasibility and cost-effectiveness of index HIVST among partners of HIV-positive clients.
Detailed Description
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Aim 1 will test the feasibility and cost-effectiveness of facility-based HIVST in OPD sites in Malawi. It will be an unblinded cluster-randomized trial and include three arms: 1) standard of care for provider-initiated testing and counseling (PITC); (2) optimized standard of care for PITC; and (3) facility-based HIVST while clients wait for routine OPD services. The standard of care arm will receive no intervention. The optimized standard of care arm will receive training and support for implementing the Malawi guidelines for PITC and morning testing. OPD clients in the facility HIVST arm will receive a HIVST demonstration and distribution, followed by uses of HIVST and private spaces for kit interpretation before receiving routine OPD services. Participants may present their self-test results to their provider, who will refer them for confirmatory HIV testing and routine ART initiation (if positive). That same day, participants from all arms will complete a brief survey upon exiting the clinic. Survey and medical record data will be compared across arms to determine whether facility HIVST is superior in regard to number of individuals tested for HIV, cost-effectiveness, number of HIV-positive individuals identified, and linkage rates for those who identify as HIV-positive.
Aim 2 will test the feasibility and cost-effectiveness of index HIVST for the sexual partners of HIV-positive clients. It will be an unblinded individually-randomized trial and include two arms: 1) standard of care partner referral slips for testing; and 2) HIVST. The standard of care arm will receive no intervention for partner notification and referral. HIV-positive clients in the HIVST arm will receive a HIVST demonstration and distribution, with instructions to give the HIVST kit to their sexual partner. Participants will be given one HIVST for each of their sexual partners who has an unknown HIV status or who tested HIV-negative more than six months prior (up to 3 HIVST kits distributed). Participants (index clients) will be given instructions on how their partner can complete the self-test and how to refer their partner(s) to care if they receive a positive result from the self-test. All participants (standard of care and HIVST arms) will complete a brief survey at the beginning of the intervention and a 4-week follow-up survey to assess primary and secondary outcomes. Medical chart reviews will be conducted for all partners reported to test HIV-positive in order to assess ART initiation rates. Survey and medical record data will be compared across arms to determine whether index HIVST is superior in regard to number of partners tested for HIV, cost-effectiveness, number of HIV-positive individuals identified, and linkage rates for those who identify as HIV-positive.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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AIm 1: Standard of care
Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.
No interventions assigned to this group
Aim 1: Optimized standard of care
Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.
Optimized PITC
Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.
Aim 1: Facility HIVST
Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).
Facility HIVST
HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.
Aim 2: Standard of care
Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.
No interventions assigned to this group
Aim 2: Index HIVST
Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).
Index HIVST
HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.
Interventions
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Optimized PITC
Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.
Facility HIVST
HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.
Index HIVST
HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide informed consent
* Being seen for OPD services at the time of the study (Aim 1)
* HIV-positive (Aim 2)
* Have at least one sex partner in the catchment area with an unknown HIV status at the time of study enrollment (Aim 2)
Exclusion Criteria
* Guardians attending clinics with OPD clients (Aim 1)
* History of intimate partner violence in the past 12 months (Aim 2)
* Fear of intimate partner violence as a consequence of participating in the study (Aim 2)
15 Years
ALL
Yes
Sponsors
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Partners in Hope, Inc.
INDUSTRY
United States Agency for International Development (USAID)
FED
Right to Care
OTHER
Ministry of Health, Malawi
OTHER_GOV
University of California, Los Angeles
OTHER
Responsible Party
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Kathryn L. Dovel, PhD
Adjunct Assistant Professor
Principal Investigators
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Kathryn Dovel, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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Partners in Hope
Lilongwe, , Malawi
Countries
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References
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Dovel K, Balakasi K, Phiri K, Shaba F, Offorjebe OA, Gupta SK, Wong V, Lungu E, Nichols BE, Masina T, Worku A, Hoffman R, Nyirenda M. Effect of index HIV self-testing for sexual partners of clients enrolled in antiretroviral therapy (ART) programs in Malawi: A randomized controlled trial. PLoS Med. 2023 Aug 4;20(8):e1004270. doi: 10.1371/journal.pmed.1004270. eCollection 2023 Aug.
Mphande M, Campbell P, Hoffman RM, Phiri K, Nyirenda M, Gupta SK, Wong V, Dovel K. Barriers and facilitators to facility HIV self-testing in outpatient settings in Malawi: a qualitative study. BMC Public Health. 2021 Dec 2;21(1):2200. doi: 10.1186/s12889-021-12213-6.
Dovel K, Shaba F, Offorjebe OA, Balakasi K, Nyirenda M, Phiri K, Gupta SK, Wong V, Tseng CH, Nichols BE, Cele R, Lungu E, Masina T, Coates TJ, Hoffman RM. Effect of facility-based HIV self-testing on uptake of testing among outpatients in Malawi: a cluster-randomised trial. Lancet Glob Health. 2020 Feb;8(2):e276-e287. doi: 10.1016/S2214-109X(19)30534-0.
Dovel K, Shaba F, Nyirenda M, Offorjebe OA, Balakasi K, Phiri K, Nichols B, Tseng CH, Bardon A, Ngona K, Hoffman R. Evaluating the integration of HIV self-testing into low-resource health systems: study protocol for a cluster-randomized control trial from EQUIP Innovations. Trials. 2018 Sep 17;19(1):498. doi: 10.1186/s13063-018-2878-y.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17-000109
Identifier Type: -
Identifier Source: org_study_id