Trial Outcomes & Findings for Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners (NCT NCT03271307)
NCT ID: NCT03271307
Last Updated: 2020-12-02
Results Overview
Same day HIV testing among OPD clients, measured by self-reports from OPD clients
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6369 participants
Primary outcome timeframe
1 day
Results posted on
2020-12-02
Participant Flow
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.
Unit of analysis: Facilities
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1951 5
|
1837 5
|
2097 5
|
135 1
|
349 2
|
|
Overall Study
COMPLETED
|
1951 5
|
1837 5
|
2097 5
|
107 1
|
258 2
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
28 0
|
91 0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
28
|
91
|
Baseline Characteristics
Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners
Baseline characteristics by cohort
| Measure |
AIm 1: Standard of Care
n=1951 Participants
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.
|
Aim 1: Optimized Standard of Care
n=1837 Participants
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
n=2097 Participants
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
n=135 Participants
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.
|
Aim 2: Index HIVST
n=349 Participants
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
n=6369 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
280 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
778 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1594 Participants
n=5 Participants
|
1543 Participants
n=7 Participants
|
1800 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
337 Participants
n=21 Participants
|
5400 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
77 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
191 Participants
n=10 Participants
|
|
Age, Continuous
|
27 years
n=5 Participants
|
36 years
n=7 Participants
|
35 years
n=5 Participants
|
35 years
n=4 Participants
|
36 years
n=21 Participants
|
35 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
1327 Participants
n=5 Participants
|
1002 Participants
n=7 Participants
|
1304 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
266 Participants
n=21 Participants
|
4004 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
624 Participants
n=5 Participants
|
835 Participants
n=7 Participants
|
793 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
2365 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1951 Participants
n=5 Participants
|
1837 Participants
n=7 Participants
|
2097 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
349 Participants
n=21 Participants
|
6369 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
Malawi
|
1951 Participants
n=5 Participants
|
1837 Participants
n=7 Participants
|
2097 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
349 Participants
n=21 Participants
|
6369 Participants
n=10 Participants
|
|
Tested for HIV ≥3months ago
|
625 Participants
n=5 Participants
|
508 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1453 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: 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.
Same day HIV testing among OPD clients, measured by self-reports from OPD clients
Outcome measures
| Measure |
AIm 1: Standard of Care
n=1951 Participants
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.
|
Aim 1: Optimized Standard of Care
n=1837 Participants
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
n=2097 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Aim 1: Proportion of Adult OPD Clients Tested for HIV
|
1951 Participants
|
1837 Participants
|
2097 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 4-weeksPopulation: 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.
HIV testing among sexual partners of HIV-positive clients within 4-weeks of study enrollment, measured by secondary reports from HIV-positive clients
Outcome measures
| Measure |
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.
|
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
n=107 Participants
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.
|
Aim 2: Index HIVST
n=258 Participants
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.
|
|---|---|---|---|---|---|
|
Aim 2: Proportion of Sexual Partners Tested for HIV
|
—
|
—
|
—
|
107 Participants
|
258 Participants
|
SECONDARY outcome
Timeframe: Same 1 day as enrollment (measuring HIV testing before clients leave the OPD clinic that day)Population: 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.
HIV-positivity rate among OPD clients, measured by self-report
Outcome measures
| Measure |
AIm 1: Standard of Care
n=1951 Participants
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.
|
Aim 1: Optimized Standard of Care
n=1837 Participants
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
n=2097 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Aim 1: HIV-positivity Rate
|
1951 Participants
|
1837 Participants
|
2097 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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
Outcome measures
| Measure |
AIm 1: Standard of Care
n=1951 Participants
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.
|
Aim 1: Optimized Standard of Care
n=1837 Participants
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
n=2097 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Aim 1: ART Initiation Among OPD Clients Tested HIV-positive
|
1951 Participants
|
1837 Participants
|
2097 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: as enrollment (measuring adverse events that occurred at the OPD clinic that 1 day)Population: 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.
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.
Outcome measures
| Measure |
AIm 1: Standard of Care
n=1951 Participants
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.
|
Aim 1: Optimized Standard of Care
n=1837 Participants
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
n=2097 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Aim 1: Presence of Non-serious Adverse Events
|
1951 Participants
|
1837 Participants
|
2097 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Total testing-related costs per person initiated on ART were calculated by study group.
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.
Outcome measures
| Measure |
AIm 1: Standard of Care
n=248 Participants
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.
|
Aim 1: Optimized Standard of Care
n=261 Participants
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
n=1063 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Aim 1: Cost Per Person Initiated ART
|
121.02 US dollar
Standard Deviation NA
Standard deviation not calculated due to nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes
|
156.27 US dollar
Standard Deviation NA
Standard deviation not calculated due to nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes
|
279.18 US dollar
Standard Deviation NA
Standard deviation not calculated due to nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes
|
—
|
—
|
SECONDARY outcome
Timeframe: 4-weeksPopulation: 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.
HIV-positivity rate measured by secondary report by the HIV-positive client
Outcome measures
| Measure |
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.
|
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
n=107 Participants
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.
|
Aim 2: Index HIVST
n=258 Participants
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.
|
|---|---|---|---|---|---|
|
Aim 2: HIV-positivity Rates Among Sexual Partners Tested for HIV
|
—
|
—
|
—
|
107 Participants
|
258 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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
Outcome measures
| Measure |
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.
|
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
n=107 Participants
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.
|
Aim 2: Index HIVST
n=258 Participants
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.
|
|---|---|---|---|---|---|
|
Aim 2: ART Initiation Among Sexual Partners Tested HIV-positive
|
—
|
—
|
—
|
107 Participants
|
258 Participants
|
SECONDARY outcome
Timeframe: 4-weeksPopulation: 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.
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
Outcome measures
| Measure |
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.
|
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
n=107 Participants
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.
|
Aim 2: Index HIVST
n=258 Participants
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.
|
|---|---|---|---|---|---|
|
Aim 2: Presence of Non-serious Adverse Events
|
—
|
—
|
—
|
107 Participants
|
258 Participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Arms in Aim 1 not included in this outcome.
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.
Outcome measures
| Measure |
AIm 1: Standard of Care
n=107 Participants
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.
|
Aim 1: Optimized Standard of Care
n=258 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Aim 2: Cost Per Person Tested HIV-Positive
|
14.9 US dollar
Standard Deviation NA
Standard deviation not calculated due to nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes
|
16.11 US dollar
Standard Deviation NA
Standard deviation not calculated due to nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 monthPopulation: Arms in Aim 1 not included in this outcome
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.
Outcome measures
| Measure |
AIm 1: Standard of Care
n=107 Participants
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.
|
Aim 1: Optimized Standard of Care
n=258 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Aim 2: Cost Per Person Initiated ART
|
16.11 US dollar
Standard Deviation NA
Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost
|
68.27 US dollar
Standard Deviation NA
Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost
|
—
|
—
|
—
|
Adverse Events
AIm 1: Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 1: Optimized Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 1: Facility HIVST
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 2: Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 2: Index HIVST
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place