HIV
Conditions
Keywords
Self Testing, Partner notification, Secondary Distribution
Brief summary
The overall objective of this study is to evaluate whether the addition of secondary distribution HIV self-test kits to existing partner notification guidelines increases the proportion of male partners who access facility-based HIV testing services, when compared to the partner notification strategy alone
Detailed description
Pregnant women 18 years of age or older who enter antenatal care at Chipata Level 1 Hospital in Lusaka, Zambia will participate. HIV-positive and HIV-negative pregnant women will be randomized to one of two groups: partner notification alone or partner notification plus secondary distribution of HIV self-test kits. Women will return to the clinic 30 days after enrollment for an exit visit during which time information about their experience with the partner notification strategies will be collected. A random sample of women and health care workers will also participate in qualitative interviews.
Interventions
BEHAVIORALHIV self-testing with partner notification.
HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm, regardless of HIV status.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Pregnant at time of enrollment based on antenatal record * Documented HIV status (either positive or negative) in antenatal record * Reports at least one current sexual partner * Willingness to provide her own contact information * Ability and willingness to provide informed consent * Intent to remain in current geographical area of residence for the duration of follow-up activities * Willingness to adhere to study procedures
Exclusion criteria
* Women who express concerns about IPV or social harms as a result of participation during the screening process will not be included. * Women who have previously enrolled in the study will not be permitted to enroll again.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility | Enrollment - 30 days post enrollment of study participant | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare Facility | Enrollment - 30 days post enrollment of study participant | 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. |
| Number of Participants Reporting Social Harms | Enrollment - 30 days post enrollment of study participant | 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. |
| Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative) | 6 months after the start of enrollment | 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. |
| Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative) | In the first two months of enrollment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported Primary Male Partner HIV Testing Completed at Any Venue | Enrollment - 30 days post enrollment of study participant | 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 |
Countries
Zambia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 58 |
| HIV-Positive Control Single strategy for partner HIV testing
Standard partner notification services. | 58 |
| 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. | 105 |
| HIV-Negative Control Single strategy for partner HIV testing
Partner notification services adapted for partners of HIV-negative women. | 105 |
| Healthcare Workers Healthcare workers who were involved in different aspects of male partner HIV testing and included study staff members. | 15 |
| Total | 341 |
Baseline characteristics
| Characteristic | HIV-Negative Control | HIV-Positive Control | HIV-Negative Intervention | HIV-Positive Intervention | Healthcare Workers | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 25 years | 26 years | 24 years | 26 years | 37 years | 25 years |
| Race and Ethnicity Not Collected | — | — | — | — | — | 0 Participants |
| Region of Enrollment Zambia | 105 Participants | 58 Participants | 105 Participants | 58 Participants | 15 Participants | 341 Participants |
| Sex: Female, Male Female | 105 Participants | 58 Participants | 105 Participants | 58 Participants | 13 Participants | 339 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 58 | 0 / 58 | 0 / 105 | 0 / 105 |
| other Total, other adverse events | 0 / 58 | 0 / 58 | 0 / 105 | 0 / 105 |
| serious Total, serious adverse events | 1 / 58 | 0 / 58 | 0 / 105 | 0 / 105 |
Outcome results
Primary
Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility
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
Time frame: Enrollment - 30 days post enrollment of study participant
Population: Data reported for all participants with a follow-up visit within 90 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV-Positive Intervention | Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility | 3 Participants |
| HIV-Positive Control | Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility | 15 Participants |
| HIV-Negative Intervention | Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility | 3 Participants |
| HIV-Negative Control | Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility | 33 Participants |
95% CI: [-35.9, -7.9]
95% CI: [-40.6, -20.8]
Secondary
Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative)
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.
Time frame: 6 months after the start of enrollment
Population: Healthcare workers involved in the provision of male partner HIV testing were interviewed to gain insights about the intervention's feasibility.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV-Positive Intervention | Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative) | Feasibility of partner notification for HIV-positive women | 9 Participants |
| HIV-Positive Intervention | Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative) | Feasibility of partner notification for HIV-negative women | 13 Participants |
| HIV-Positive Intervention | Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative) | Feasibility of HIV self-testing for HIV-positive women | 10 Participants |
| HIV-Positive Intervention | 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
Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative)
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.
Time frame: In the first two months of enrollment
Population: This subsample of participants is based on study arm and woman's HIV status.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV-Positive Intervention | Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative) | Acceptability of partner notification | 6 Participants |
| HIV-Positive Intervention | Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative) | Acceptability of HIV self-testing | 9 Participants |
| HIV-Positive Control | Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative) | Acceptability of HIV self-testing | NA Participants |
| HIV-Positive Control | Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative) | Acceptability of partner notification | 4 Participants |
| HIV-Negative Intervention | Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative) | Acceptability of partner notification | 5 Participants |
| HIV-Negative Intervention | Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative) | Acceptability of HIV self-testing | 8 Participants |
| HIV-Negative Control | Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative) | Acceptability of partner notification | 3 Participants |
| HIV-Negative Control | Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative) | Acceptability of HIV self-testing | NA Participants |
Secondary
Number of Participants Reporting Social Harms
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.
Time frame: Enrollment - 30 days post enrollment of study participant
Population: Data reported for all participants with a follow-up visit within 90 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV-Positive Intervention | Number of Participants Reporting Social Harms | 0 Participants |
| HIV-Positive Control | Number of Participants Reporting Social Harms | 1 Participants |
| HIV-Negative Intervention | Number of Participants Reporting Social Harms | 0 Participants |
| HIV-Negative Control | Number of Participants Reporting Social Harms | 0 Participants |
Secondary
Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare Facility
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.
Time frame: Enrollment - 30 days post enrollment of study participant
Population: Data reported for all participants with a follow-up visit within 90 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV-Positive Intervention | Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare Facility | 1 Participants |
| HIV-Positive Control | Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare Facility | 4 Participants |
| HIV-Negative Intervention | Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare Facility | 0 Participants |
| HIV-Negative Control | Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare Facility | 9 Participants |
95% CI: [-13.6, 2.8]
Other Pre-specified
Number of Participants Who Reported Primary Male Partner HIV Testing Completed at Any Venue
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
Time frame: Enrollment - 30 days post enrollment of study participant
Population: Data reported for all participants with a follow-up visit within 90 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV-Positive Intervention | Number of Participants Who Reported Primary Male Partner HIV Testing Completed at Any Venue | 36 Participants |
| HIV-Positive Control | Number of Participants Who Reported Primary Male Partner HIV Testing Completed at Any Venue | 19 Participants |
| HIV-Negative Intervention | Number of Participants Who Reported Primary Male Partner HIV Testing Completed at Any Venue | 80 Participants |
| HIV-Negative Control | Number of Participants Who Reported Primary Male Partner HIV Testing Completed at Any Venue | 54 Participants |
95% CI: [23, 58.4]
95% CI: [10.7, 36]