Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners

• ClinicalTrials.gov Identifier: NCT03271307
• Recruitment Status: Completed
• First Posted: September 5, 2017
• Results First Posted: December 2, 2020
• Last Update Posted: December 2, 2020
• Sponsor: University of California, Los Angeles
• Collaborators: Partners in Hope; United States Agency for International Development (USAID); Right to Care; Ministry of Health, Malawi
• Information provided by (Responsible Party): Kathryn L. Dovel, PhD, University of California, Los Angeles

Tracking Information

• First Submitted Date: August 31, 2017
• First Posted Date: September 5, 2017
• Results First Submitted Date: May 15, 2019
• Results First Posted Date: December 2, 2020
• Last Update Posted Date: December 2, 2020
• Actual Study Start Date: September 25, 2017
• Actual Primary Completion Date: June 13, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 6, 2020)

• Aim 1: Proportion of Adult OPD Clients Tested for HIV [ Time Frame: 1 day ]
  Same day HIV testing among OPD clients, measured by self-reports from OPD clients
• Aim 2: Proportion of Sexual Partners Tested for HIV [ Time Frame: 4-weeks ]
  HIV testing among sexual partners of HIV-positive clients within 4-weeks of study enrollment, measured by secondary reports from HIV-positive clients

Original Primary Outcome Measures (submitted: August 31, 2017)

• Quantity of patients tested for HIV in outpatient departments and STI clinics [ Time Frame: 18 months ]
  The study will evaluate whether HIV self-testing in a group setting in patient waiting areas of OPD and STI clinics is superior in regard to the number of individuals tested compared to optimized standard of care (provider-initiated testing and counseling).
• Cost-effectiveness of HIV self-testing in outpatient departments and STI clinics [ Time Frame: 18 months ]
  The study will evaluate whether HIV self-testing in a group setting in patient waiting areas of OPD and STI clinics is cost-effectiveness when compared to optimized standard of care (provider-initiated testing and counseling).
• Quantity of index partners tested for HIV [ Time Frame: 18 months ]
  The study will evaluate whether providing HIV-positive index clients with HIV self-test kits to be distributed to their sex partners results in a greater number of partners tested as compared to optimized standard of care for partner notification and testing (referral slips).
• Cost-effectiveness of distributing HIV self-test kits for index partners [ Time Frame: 18 months ]
  The study will evaluate whether providing index partners with HIV self-test kits is cost-effective compared to optimized standard of care for partner notification and testing (referral slips).

Current Secondary Outcome Measures (submitted: November 6, 2020)

• Aim 1: HIV-positivity Rate [ Time Frame: Same 1 day as enrollment (measuring HIV testing before clients leave the OPD clinic that day) ]
  HIV-positivity rate among OPD clients, measured by self-report
• Aim 1: ART Initiation Among OPD Clients Tested HIV-positive [ Time Frame: 3 months ]
  ART initiation within 3-months after being identified as HIV-positive within the study, measured by medical chart reviews of all Partners in Hope supported health facilities in participating districts
• Aim 1: Presence of Non-serious Adverse Events [ Time Frame: as enrollment (measuring adverse events that occurred at the OPD clinic that 1 day) ]
  Presence of adverse events due to the HIV testing intervention, including coercion to test, share test results, and unwanted status disclosure, measured by self-report on the day the intervention was delivered.
• Aim 1: Cost Per Person Initiated ART [ Time Frame: 3 months ]
  Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual initiated ART by each arm, respectively. All costs in 2017 US$. Cost calculations do not include cost of ART. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per ART initiate. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.
• Aim 2: HIV-positivity Rates Among Sexual Partners Tested for HIV [ Time Frame: 4-weeks ]
  HIV-positivity rate measured by secondary report by the HIV-positive client
• Aim 2: ART Initiation Among Sexual Partners Tested HIV-positive [ Time Frame: 3 months ]
  ART initiation within 3-months after being identified as HIV-positive within the study, measured by medical chart reviews of all Partners in Hope supported health facilities in participating districts
• Aim 2: Presence of Non-serious Adverse Events [ Time Frame: 4-weeks ]
  Presence of adverse events due to the HIV testing intervention, including coercion to test, share test results, unwanted status disclosure, and interpersonal violence measured by self-report by the HIV-positive client
• Aim 2: Cost Per Person Tested HIV-Positive [ Time Frame: 1 month ]
  Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual tested HIV-positive by each arm, respectively. All costs in 2017 US$. Cost calculations include all costs associated with HIV testing. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per HIV-positive individual identified. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.
• Aim 2: Cost Per Person Initiated ART [ Time Frame: 3 month ]
  Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual initiated ART by each arm, respectively. All costs in 2017 US$. Cost calculations do not include cost of ART. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per ART initiate. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.

Original Secondary Outcome Measures (submitted: August 31, 2017)

• Acceptability of HIV self-testing in waiting areas of OPD and STI clinics [ Time Frame: 18 months ]
  The study will assess the acceptability of HIV self-testing in a group setting in waiting areas of OPD and STI clinics.
• Testing yield of HIV-positive individuals in OPD and STI clinics [ Time Frame: 18 months ]
  The study will evaluate whether HIV self-testing in waiting areas of OPD and STI clinics is superior to optimized standard of care (provider-initiated testing and counseling) in regard to the number of HIV-positive individuals identified.
• Linkage rate for HIV-positive individuals [ Time Frame: 18 months ]
  The study will evaluate whether HIV self-testing in waiting areas of OPD and STI clinics is superior to optimized standard of care (provider-initiated testing and counseling) in regard to the rate of linkage to care for those who identify as HIV-positive.
• Acceptability of HIV self-testing for index partner testing [ Time Frame: 18 months ]
  The study will assess the acceptability of providing index clients with HIV self-test kits to distribute to sex partners for testing.
• Testing yield of HIV-positive index partners [ Time Frame: 18 months ]
  The study will evaluate whether providing index partners with HIV self-test kits is superior to optimized standard of care for partner notification and testing (referral slips) in regard to identifying HIV-positive partners.
• Linkage rate for HIV-positive index partners [ Time Frame: 18 months ]
  The study will evaluate whether providing index partners with HIV self-test kits is superior to optimized standard of care for partner notification and testing (referral slips) in regard to the rate of linkage to care for those who identify as HIV-positive.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Diagnostic

• Condition: HIV Infections

Intervention

• Behavioral: 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.
  Other Name: Optimized standard of care
• Diagnostic Test: 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.
• Diagnostic Test: 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.

Study Arms

• No Intervention: 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.
• Experimental: 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.
  Intervention: Behavioral: Optimized PITC
• Experimental: 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).
  Intervention: Diagnostic Test: Facility HIVST
• No Intervention: 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.
• Experimental: 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).
  Intervention: Diagnostic Test: Index HIVST

Publications *

• 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. Erratum In: Lancet Glob Health. 2020 Mar;8(3):e340.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 6, 2020): 6369
• Original Estimated Enrollment (submitted: August 31, 2017): 22500
• Actual Study Completion Date: January 25, 2019
• Actual Primary Completion Date: June 13, 2018 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Malawi

Administrative Information

• NCT Number: NCT03271307
• Other Study ID Numbers: 17-000109
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Kathryn L. Dovel, PhD, University of California, Los Angeles
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, Los Angeles
• Original Study Sponsor: Same as current

Collaborators

• Partners in Hope
• United States Agency for International Development (USAID)
• Right to Care
• Ministry of Health, Malawi

Investigators

• Principal Investigator: Kathryn Dovel, PhD, MPH; University of California, Los Angeles

• PRS Account: University of California, Los Angeles
• Verification Date: November 2020