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

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: HIV Infections
• Interventions: Behavioral: Optimized PITC; Diagnostic Test: Facility HIVST; Diagnostic Test: Index HIVST
• Enrollment: 6369

Participant Flow

Recruitment Details	Participants were recruited during routine health services at participating facilities. For Aim 1, participants were recruited from September 18, 2017 - February 19, 2018. For Aim 2, participants were recruited from March 21, 2018 - June 13, 2018.
Pre-assignment Details

Arm/Group Title	AIm 1: Standard of Care		Aim 1: Optimized Standard of Care		Aim 1: Facility HIVST		Aim 2: Standard of Care		Aim 2: Index HIVST
Arm/Group Description	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.		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.		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.		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.		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.
Period Title: Overall Study
	Number of participants	Number of units (Facilities)	Number of participants	Number of units (Facilities)	Number of participants	Number of units (Facilities)	Number of participants	Number of units (Facilities)	Number of participants	Number of units (Facilities)
Started	1951	5	1837	5	2097	5	135	1	349	2
Completed	1951	5	1837	5	2097	5	107	1	258	2
Not Completed	0	0	0	0	0	0	28	0	91	0
Reason Not Completed
Lost to Follow-up	0		0		0		28		91

Baseline Characteristics

Arm/Group Title		AIm 1: Standard of Care	Aim 1: Optimized Standard of Care	Aim 1: Facility HIVST	Aim 2: Standard of Care	Aim 2: Index HIVST	Total
Arm/Group Description		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.	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.	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.	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.	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.	Total of all reporting groups
Overall Number of Baseline Participants		1951	1837	2097	135	349	6369
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1951 participants	1837 participants	2097 participants	135 participants	349 participants	6369 participants
	<=18 years	280 14.4%	223 12.1%	264 12.6%	5 3.7%	6 1.7%	778 12.2%
	Between 18 and 65 years	1594 81.7%	1543 84.0%	1800 85.8%	126 93.3%	337 96.6%	5400 84.8%
	>=65 years	77 3.9%	71 3.9%	33 1.6%	4 3.0%	6 1.7%	191 3.0%
Age, Continuous; Median (Inter-Quartile Range); Unit of measure: Years
	Number Analyzed	1951 participants	1837 participants	2097 participants	135 participants	349 participants	6369 participants
		27; (26 to 35)	36; (25 to 48)	35; (28 to 44)	35; (29 to 45)	36; (28 to 43)	35; (27 to 44)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1951 participants	1837 participants	2097 participants	135 participants	349 participants	6369 participants
	Female	1327 68.0%	1002 54.5%	1304 62.2%	105 77.8%	266 76.2%	4004 62.9%
	Male	624 32.0%	835 45.5%	793 37.8%	30 22.2%	83 23.8%	2365 37.1%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1951 participants	1837 participants	2097 participants	135 participants	349 participants	6369 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	1951 100.0%	1837 100.0%	2097 100.0%	135 100.0%	349 100.0%	6369 100.0%
	White	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
Malawi	Number Analyzed	1951 participants	1837 participants	2097 participants	135 participants	349 participants	6369 participants
		1951 100.0%	1837 100.0%	2097 100.0%	135 100.0%	349 100.0%	6369 100.0%
Tested for HIV ≥3months ago; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1951 participants	1837 participants	2097 participants	135 participants	349 participants	6369 participants
		625 32.0%	508 27.7%	320 15.3%	0 0.0%	0 0.0%	1453 22.8%

Outcome Measures

1. Primary Outcome

Title	Aim 1: Proportion of Adult OPD Clients Tested for HIV
Description	Same day HIV testing among OPD clients, measured by self-reports from OPD clients
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.

Arm/Group Title	AIm 1: Standard of Care	Aim 1: Optimized Standard of Care	Aim 1: Facility HIVST	Aim 2: Standard of Care	Aim 2: Index HIVST
Arm/Group Description:	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	1951	1837	2097	0	0
Measure Type: Count of Participants; Unit of Measure: Participants
	1951 100.0%	1837 100.0%	2097 100.0%

2. Primary Outcome

Title	Aim 2: Proportion of Sexual Partners Tested for HIV
Description	HIV testing among sexual partners of HIV-positive clients within 4-weeks of study enrollment, measured by secondary reports from HIV-positive clients
Time Frame	4-weeks

Outcome Measure Data

Analysis Population Description

Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.

Arm/Group Title	AIm 1: Standard of Care	Aim 1: Optimized Standard of Care	Aim 1: Facility HIVST	Aim 2: Standard of Care	Aim 2: Index HIVST
Arm/Group Description:	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	0	0	0	107	258
Measure Type: Count of Participants; Unit of Measure: Participants
				107 100.0%	258 100.0%

3. Secondary Outcome

Title	Aim 1: HIV-positivity Rate
Description	HIV-positivity rate among OPD clients, measured by self-report
Time Frame	Same 1 day as enrollment (measuring HIV testing before clients leave the OPD clinic that day)

Outcome Measure Data

Analysis Population Description

Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.

Arm/Group Title	AIm 1: Standard of Care	Aim 1: Optimized Standard of Care	Aim 1: Facility HIVST	Aim 2: Standard of Care	Aim 2: Index HIVST
Arm/Group Description:	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	1951	1837	2097	0	0
Measure Type: Count of Participants; Unit of Measure: Participants
	1951 100.0%	1837 100.0%	2097 100.0%

4. Secondary Outcome

Title	Aim 1: ART Initiation Among OPD Clients Tested HIV-positive
Description	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
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.

Arm/Group Title	AIm 1: Standard of Care	Aim 1: Optimized Standard of Care	Aim 1: Facility HIVST	Aim 2: Standard of Care	Aim 2: Index HIVST
Arm/Group Description:	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	1951	1837	2097	0	0
Measure Type: Count of Participants; Unit of Measure: Participants
	1951 100.0%	1837 100.0%	2097 100.0%

5. Secondary Outcome

Title	Aim 1: Presence of Non-serious Adverse Events
Description	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.
Time Frame	as enrollment (measuring adverse events that occurred at the OPD clinic that 1 day)

Outcome Measure Data

Analysis Population Description

Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.

Arm/Group Title	AIm 1: Standard of Care	Aim 1: Optimized Standard of Care	Aim 1: Facility HIVST	Aim 2: Standard of Care	Aim 2: Index HIVST
Arm/Group Description:	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	1951	1837	2097	0	0
Measure Type: Count of Participants; Unit of Measure: Participants
	1951 100.0%	1837 100.0%	2097 100.0%

6. Secondary Outcome

Title	Aim 1: Cost Per Person Initiated ART
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Total testing-related costs per person initiated on ART were calculated by study group.

Arm/Group Title	Aim 1: Standard of Care	Aim 1: Optimized Standard of Care	Aim 1: Facility HIVST
Arm/Group Description:	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.	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.	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.
Overall Number of Participants Analyzed	248	261	1063
Mean (Standard Deviation); Unit of Measure: US dollar
	121.02 [1] (NA)	156.27 [1] (NA)	279.18 [1] (NA)

[1]

Standard deviation not calculated due to nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes

7. Secondary Outcome

Title	Aim 2: HIV-positivity Rates Among Sexual Partners Tested for HIV
Description	HIV-positivity rate measured by secondary report by the HIV-positive client
Time Frame	4-weeks

Outcome Measure Data

Analysis Population Description

Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.

Arm/Group Title	AIm 1: Standard of Care	Aim 1: Optimized Standard of Care	Aim 1: Facility HIVST	Aim 2: Standard of Care	Aim 2: Index HIVST
Arm/Group Description:	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	0	0	0	107	258
Measure Type: Count of Participants; Unit of Measure: Participants
				107 100.0%	258 100.0%

8. Secondary Outcome

Title	Aim 2: ART Initiation Among Sexual Partners Tested HIV-positive
Description	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
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.

Arm/Group Title	AIm 1: Standard of Care	Aim 1: Optimized Standard of Care	Aim 1: Facility HIVST	Aim 2: Standard of Care	Aim 2: Index HIVST
Arm/Group Description:	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	0	0	0	107	258
Measure Type: Count of Participants; Unit of Measure: Participants
				107 100.0%	258 100.0%

9. Secondary Outcome

Title	Aim 2: Presence of Non-serious Adverse Events
Description	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
Time Frame	4-weeks

Outcome Measure Data

Analysis Population Description

Descriptive statistics (mean, standard deviation, median, inter-quartile range, and frequency distribution) were generated for the demographic and clinical information to characterize the study population.

Arm/Group Title	AIm 1: Standard of Care	Aim 1: Optimized Standard of Care	Aim 1: Facility HIVST	Aim 2: Standard of Care	Aim 2: Index HIVST
Arm/Group Description:	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	0	0	0	107	258
Measure Type: Count of Participants; Unit of Measure: Participants
				107 100.0%	258 100.0%

10. Secondary Outcome

Title	Aim 2: Cost Per Person Tested HIV-Positive
Description	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.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Arms in Aim 1 not included in this outcome.

Arm/Group Title	Aim 2: Standard of Care	Aim 2: Index HIVST
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	107	258
Mean (Standard Deviation); Unit of Measure: US dollar
	14.9 [1] (NA)	16.11 [1] (NA)

[1]

Standard deviation not calculated due to nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes

11. Secondary Outcome

Title	Aim 2: Cost Per Person Initiated ART
Description	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.
Time Frame	3 month

Outcome Measure Data

Analysis Population Description

Arms in Aim 1 not included in this outcome

Arm/Group Title	Aim 2: Standard of Care	Aim 2: Index HIVST
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	107	258
Mean (Standard Deviation); Unit of Measure: US dollar
	16.11 [1] (NA)	68.27 [1] (NA)

[1]

Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost

Adverse Events

Time Frame	For Aim 1 (Facility-based HIVST at OPD), adverse events were collected the same day as study enrollment, intervention, and assessment of outcomes. For Aim 2 (Index HIVST), adverse events were collected 4-weeks after study enrollment and delivery of the intervention (HIVST).
Adverse Event Reporting Description	For Aim 1, adverse events included (1) coercion to test or share test results; and (2) unwanted status disclosure. Data were collected from follow-up surveys with OPD clients enrolled in the study. For Aim 2, adverse events included (1) coercion to test or share test results; (2) unwanted status disclosure; (3) intimate personal violence to the HIV-positive client; and (4) end of the romantic relationship. Data were collected from follow-up surveys with ART clients enrolled in the study.
Arm/Group Title	AIm 1: Standard of Care	Aim 1: Optimized Standard of Care	Aim 1: Facility HIVST	Aim 2: Standard of Care	Aim 2: Index HIVST
Arm/Group Description	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.	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.	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.	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.	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.
All-Cause Mortality
	AIm 1: Standard of Care	Aim 1: Optimized Standard of Care	Aim 1: Facility HIVST	Aim 2: Standard of Care	Aim 2: Index HIVST
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/1951 (0.00%)	0/1837 (0.00%)	0/2097 (0.00%)	0/107 (0.00%)	0/258 (0.00%)
Serious Adverse Events
	AIm 1: Standard of Care	Aim 1: Optimized Standard of Care	Aim 1: Facility HIVST	Aim 2: Standard of Care	Aim 2: Index HIVST
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/1951 (0.00%)	0/1837 (0.00%)	0/2097 (0.00%)	0/107 (0.00%)	0/258 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	AIm 1: Standard of Care	Aim 1: Optimized Standard of Care	Aim 1: Facility HIVST	Aim 2: Standard of Care	Aim 2: Index HIVST
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/1951 (0.00%)	0/1837 (0.00%)	0/2097 (0.00%)	0/107 (0.00%)	0/258 (0.00%)

Limitations and Caveats

Aim 2 data rely on secondary reports from ART clients regarding HIV testing and test results for their sexual partner. Secondary reports may be bias, however, are findings are similar to other HIVST studies.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Kathryn Dovel
• Organization: University of California Los Angeles
• Phone: 7143303416
• EMail: KDovel@mednet.ucla.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Kathryn L. Dovel, PhD, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03271307
• Other Study ID Numbers: 17-000109
• First Submitted: August 31, 2017
• First Posted: September 5, 2017
• Results First Submitted: May 15, 2019
• Results First Posted: December 2, 2020
• Last Update Posted: December 2, 2020