Trial Outcomes & Findings for Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women (NCT NCT04124536)
NCT ID: NCT04124536
Last Updated: 2021-07-21
Results Overview
The number of participants who report their primary male partners getting tested for HIV at a healthcare facility when presented with partner notification plus secondary distribution of HIV self-test kits compared to partner notification alone
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
341 participants
Primary outcome timeframe
Enrollment - 30 days post enrollment of study participant
Results posted on
2021-07-21
Participant Flow
Participant milestones
| Measure |
HIV-Positive Intervention
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Positive Control
Single strategy for partner HIV testing
Standard partner notification services.
|
HIV-Negative Intervention
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Negative Control
Single strategy for partner HIV testing
Partner notification services adapted for partners of HIV-negative women.
|
Healthcare Workers
Healthcare workers were interviewed about the trial interventions, to gain insights into its feasibility.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
105
|
105
|
15
|
|
Overall Study
COMPLETED
|
47
|
53
|
102
|
98
|
15
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
3
|
7
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
HIV-Positive Intervention
n=58 Participants
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Positive Control
n=58 Participants
Single strategy for partner HIV testing
Standard partner notification services.
|
HIV-Negative Intervention
n=105 Participants
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Negative Control
n=105 Participants
Single strategy for partner HIV testing
Partner notification services adapted for partners of HIV-negative women.
|
Healthcare Workers
n=15 Participants
Healthcare workers who were involved in different aspects of male partner HIV testing and included study staff members.
|
Total
n=341 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
26 years
n=58 Participants
|
26 years
n=58 Participants
|
24 years
n=105 Participants
|
25 years
n=105 Participants
|
37 years
n=15 Participants
|
25 years
n=341 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=58 Participants
|
58 Participants
n=58 Participants
|
105 Participants
n=105 Participants
|
105 Participants
n=105 Participants
|
13 Participants
n=15 Participants
|
339 Participants
n=341 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=58 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=105 Participants
|
2 Participants
n=15 Participants
|
2 Participants
n=341 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Zambia
|
58 Participants
n=58 Participants
|
58 Participants
n=58 Participants
|
105 Participants
n=105 Participants
|
105 Participants
n=105 Participants
|
15 Participants
n=15 Participants
|
341 Participants
n=341 Participants
|
PRIMARY outcome
Timeframe: Enrollment - 30 days post enrollment of study participantPopulation: Data reported for all participants with a follow-up visit within 90 days of randomization
The number of participants who report their primary male partners getting tested for HIV at a healthcare facility when presented with partner notification plus secondary distribution of HIV self-test kits compared to partner notification alone
Outcome measures
| Measure |
HIV-Positive Intervention
n=47 Participants
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Positive Control
n=53 Participants
Single strategy for partner HIV testing
Standard partner notification services.
|
HIV-Negative Intervention
n=102 Participants
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Negative Control
n=98 Participants
Single strategy for partner HIV testing
Partner notification services adapted for partners of HIV-negative women.
|
|---|---|---|---|---|
|
Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility
|
3 Participants
|
15 Participants
|
3 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Enrollment - 30 days post enrollment of study participantPopulation: Data reported for all participants with a follow-up visit within 90 days of randomization
The number of couples getting tested for HIV when presented with partner notification plus secondary distribution of HIV self-test kits will be compared to partner notification alone.
Outcome measures
| Measure |
HIV-Positive Intervention
n=47 Participants
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Positive Control
n=53 Participants
Single strategy for partner HIV testing
Standard partner notification services.
|
HIV-Negative Intervention
n=102 Participants
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Negative Control
n=98 Participants
Single strategy for partner HIV testing
Partner notification services adapted for partners of HIV-negative women.
|
|---|---|---|---|---|
|
Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare Facility
|
1 Participants
|
4 Participants
|
0 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Enrollment - 30 days post enrollment of study participantPopulation: Data reported for all participants with a follow-up visit within 90 days of randomization
The number of participants reporting social harms associated with the HIV testing approaches. Participants were asked about social harms related to trial participation, including perceived stigma, discrimination, and intimate partner violence.
Outcome measures
| Measure |
HIV-Positive Intervention
n=47 Participants
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Positive Control
n=53 Participants
Single strategy for partner HIV testing
Standard partner notification services.
|
HIV-Negative Intervention
n=102 Participants
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Negative Control
n=98 Participants
Single strategy for partner HIV testing
Partner notification services adapted for partners of HIV-negative women.
|
|---|---|---|---|---|
|
Number of Participants Reporting Social Harms
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months after the start of enrollmentPopulation: Healthcare workers involved in the provision of male partner HIV testing were interviewed to gain insights about the intervention's feasibility.
To gain deeper insights about the feasibility of male partner HIV testing strategies, healthcare workers from the study site were asked to participate in in-depth interviews. Participating healthcare workers were involved in different aspects of male partner HIV testing and included study staff members. Feasibility was defined as a positive rating about the intervention's potential performance in real-life conditions at the clinic and community levels.
Outcome measures
| Measure |
HIV-Positive Intervention
n=15 Participants
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Positive Control
Single strategy for partner HIV testing
Standard partner notification services.
|
HIV-Negative Intervention
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Negative Control
Single strategy for partner HIV testing
Partner notification services adapted for partners of HIV-negative women.
|
|---|---|---|---|---|
|
Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative)
Feasibility of partner notification for HIV-positive women
|
9 Participants
|
—
|
—
|
—
|
|
Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative)
Feasibility of partner notification for HIV-negative women
|
13 Participants
|
—
|
—
|
—
|
|
Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative)
Feasibility of HIV self-testing for HIV-positive women
|
10 Participants
|
—
|
—
|
—
|
|
Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative)
Feasibility of HIV self-testing for HIV-negative women
|
15 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: In the first two months of enrollmentPopulation: This subsample of participants is based on study arm and woman's HIV status.
To gain deeper insights about the acceptability of the different male partner HIV testing strategies, subsamples of participants were selected based on study arm (intervention vs. control) and woman's HIV status (positive vs. negative). For the outcome measure, acceptability was defined as a positive rating of male partner HIV testing strategies from participants based on their experiences.
Outcome measures
| Measure |
HIV-Positive Intervention
n=11 Participants
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Positive Control
n=10 Participants
Single strategy for partner HIV testing
Standard partner notification services.
|
HIV-Negative Intervention
n=10 Participants
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Negative Control
n=8 Participants
Single strategy for partner HIV testing
Partner notification services adapted for partners of HIV-negative women.
|
|---|---|---|---|---|
|
Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative)
Acceptability of partner notification
|
6 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative)
Acceptability of HIV self-testing
|
9 Participants
|
NA Participants
According to the trial design, participants in the control group did not receive HIV self-test kits to distribute to their male partners. As such, they were not in a position to comment on acceptability.
|
8 Participants
|
NA Participants
According to the trial design, participants in the control group did not receive HIV self-test kits to distribute to their male partners. As such, they were not in a position to comment on acceptability.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment - 30 days post enrollment of study participantPopulation: Data reported for all participants with a follow-up visit within 90 days of randomization
The number of participants who report their primary male partners getting tested for HIV at any venue when presented with partner notification plus secondary distribution of HIV self-test kits (SD-HIVST) compared to partner notification alone
Outcome measures
| Measure |
HIV-Positive Intervention
n=47 Participants
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Positive Control
n=53 Participants
Single strategy for partner HIV testing
Standard partner notification services.
|
HIV-Negative Intervention
n=102 Participants
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Negative Control
n=98 Participants
Single strategy for partner HIV testing
Partner notification services adapted for partners of HIV-negative women.
|
|---|---|---|---|---|
|
Number of Participants Who Reported Primary Male Partner HIV Testing Completed at Any Venue
|
36 Participants
|
19 Participants
|
80 Participants
|
54 Participants
|
Adverse Events
HIV-Positive Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
HIV-Positive Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV-Negative Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV-Negative Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV-Positive Intervention
n=58 participants at risk
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Positive Control
n=58 participants at risk
Single strategy for partner HIV testing
Standard partner notification services.
|
HIV-Negative Intervention
n=105 participants at risk
Combination strategy for partner HIV testing
HIV self-testing with partner notification. HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm.
|
HIV-Negative Control
n=105 participants at risk
Single strategy for partner HIV testing
Partner notification services adapted for partners of HIV-negative women.
|
|---|---|---|---|---|
|
Infections and infestations
Maternal death
|
1.7%
1/58 • From study enrollment through follow-up, a total of approximately 30 -90 days.
Adverse events were documented for all pregnant women in the four arms of the primary trial. Because healthcare workers were not recipients of the strategies under evaluation (either in the control or intervention arms), adverse events were not assessed in this group. Instead, healthcare workers underwent interviews to assess the feasibility of these different strategies.
|
0.00%
0/58 • From study enrollment through follow-up, a total of approximately 30 -90 days.
Adverse events were documented for all pregnant women in the four arms of the primary trial. Because healthcare workers were not recipients of the strategies under evaluation (either in the control or intervention arms), adverse events were not assessed in this group. Instead, healthcare workers underwent interviews to assess the feasibility of these different strategies.
|
0.00%
0/105 • From study enrollment through follow-up, a total of approximately 30 -90 days.
Adverse events were documented for all pregnant women in the four arms of the primary trial. Because healthcare workers were not recipients of the strategies under evaluation (either in the control or intervention arms), adverse events were not assessed in this group. Instead, healthcare workers underwent interviews to assess the feasibility of these different strategies.
|
0.00%
0/105 • From study enrollment through follow-up, a total of approximately 30 -90 days.
Adverse events were documented for all pregnant women in the four arms of the primary trial. Because healthcare workers were not recipients of the strategies under evaluation (either in the control or intervention arms), adverse events were not assessed in this group. Instead, healthcare workers underwent interviews to assess the feasibility of these different strategies.
|
Other adverse events
Adverse event data not reported
Additional Information
Benjamin Chi, MD, MSc
University of North Carolina at Chapel Hill
Phone: 919-445-4174
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place