Clinical trial NCT03271307: Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners
Official title: Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: self-test
testing
cost-effectiveness
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Partners in Hope, Inc.
name: United States Agency for International Development (USAID)
name: Right to Care
name: Ministry of Health, Malawi
First posted: 2017-09-05
Enrollment: 6369
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will include two arms and methodology: (Aim 1) A cluster-randomized trial comparing HIV testing strategies for OPD clients, clustered by health facility; and (Aim 2) A individual-randomized trial comparing HIV testing strategies for partners of HIV-positive clients.
Primary purpose: DIAGNOSTIC

Brief summary: This study comprises two trials to evaluate the feasibility and cost-effectiveness of HIV self-testing strategies compared to standard of care among clients in outpatient departments (OPD; Aim 1) and the sexual partners of HIV-positive clients (index testing; Aim 2).

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: The study includes two unblinded trials to evaluate the feasibility and cost-effectiveness of HIVST strategies among adults in Malawi.

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.

Eligibility criteria: Inclusion Criteria:

* 15 years or older
* 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:

* Currently enrolled in the INTERVAL study
* 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)

Primary outcomes:
measure: Aim 1: Proportion of Adult OPD Clients Tested for HIV
timeFrame: 1 day
measure: Aim 2: Proportion of Sexual Partners Tested for HIV
timeFrame: 4-weeks
Secondary outcomes:
measure: Aim 1: HIV-positivity Rate
timeFrame: Same 1 day as enrollment (measuring HIV testing before clients leave the OPD clinic that day)
measure: Aim 1: ART Initiation Among OPD Clients Tested HIV-positive
timeFrame: 3 months
measure: Aim 1: Presence of Non-serious Adverse Events
timeFrame: as enrollment (measuring adverse events that occurred at the OPD clinic that 1 day)
measure: Aim 1: Cost Per Person Initiated ART
timeFrame: 3 months
measure: Aim 2: HIV-positivity Rates Among Sexual Partners Tested for HIV
timeFrame: 4-weeks
measure: Aim 2: ART Initiation Among Sexual Partners Tested HIV-positive
timeFrame: 3 months
measure: Aim 2: Presence of Non-serious Adverse Events
timeFrame: 4-weeks
measure: Aim 2: Cost Per Person Tested HIV-Positive
timeFrame: 1 month
measure: Aim 2: Cost Per Person Initiated ART
timeFrame: 3 month
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Partners in Hope
Study officials:
affiliation: University of California, Los Angeles
name: Kathryn Dovel, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.