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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI131060 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | In addition to standard partner notification services, the intervention arm will receive HIV self-test kits and structured counseling about HIVST, regardless of HIV status. |
|
| Control | No Intervention | Standard partner notification services, regardless of HIV status. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV self-testing with partner notification. | Behavioral | HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm, regardless of HIV status. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Enrollment - 30 days post enrollment of study participant |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Enrollment - 30 days post enrollment of study participant |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Enrollment - 30 days post enrollment of study participant |
Inclusion Criteria
Exclusion Criteria
Pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Ben Chi, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chipata Health Centre | Lusaka | Zambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34735862 | Derived | Mutale W, Freeborn K, Graybill LA, Lusaka MM, Mollan KR, Mweemba O, Kasaro M, Lungu R, Kumwenda A, Saidi F, Powers KA, Maman S, Rosenberg NE, Chi BH. Addition of HIV self-test kits to partner notification services to increase HIV testing of male partners of pregnant women in Zambia: two parallel randomised trials. Lancet Glob Health. 2021 Dec;9(12):e1719-e1729. doi: 10.1016/S2214-109X(21)00393-4. Epub 2021 Nov 1. |
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Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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9 to 36 months following publication
IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | HIV-Positive Control | Single strategy for partner HIV testing Standard partner notification services. |
| FG002 | 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. |
| FG003 | HIV-Negative Control | Single strategy for partner HIV testing Partner notification services adapted for partners of HIV-negative women. |
| FG004 | Healthcare Workers | Healthcare workers were interviewed about the trial interventions, to gain insights into its feasibility. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | HIV-Positive Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Data reported for all participants with a follow-up visit within 90 days of randomization | Posted | Count of Participants | Participants | Enrollment - 30 days post enrollment of study participant |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Maternal death | Infections and infestations | Systematic Assessment | Maternal death due to meningoencephalitis due to advanced HIV disease. This condition was deemed unrelated to study participation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Chi, MD, MSc | University of North Carolina at Chapel Hill | 919-445-4174 | bchi@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2019 | Apr 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016358 | Contact Tracing |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| 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. |
| Enrollment - 30 days post enrollment of study participant |
| 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. | 6 months after the start of enrollment |
| 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. | In the first two months of enrollment |
Single strategy for partner HIV testing Standard partner notification services. |
| BG002 | 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. |
| BG003 | HIV-Negative Control | Single strategy for partner HIV testing Partner notification services adapted for partners of HIV-negative women. |
| BG004 | Healthcare Workers | Healthcare workers who were involved in different aspects of male partner HIV testing and included study staff members. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| HIV-Positive Control |
Single strategy for partner HIV testing Standard partner notification services. |
| OG002 | 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. |
| OG003 | HIV-Negative Control | Single strategy for partner HIV testing Partner notification services adapted for partners of HIV-negative women. |
|
|
|
| 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. | Data reported for all participants with a follow-up visit within 90 days of randomization | Posted | Count of Participants | Participants | Enrollment - 30 days post enrollment of study participant |
|
|
|
|
| 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. | Data reported for all participants with a follow-up visit within 90 days of randomization | Posted | Count of Participants | Participants | Enrollment - 30 days post enrollment of study participant |
|
|
|
| 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. | Healthcare workers involved in the provision of male partner HIV testing were interviewed to gain insights about the intervention's feasibility. | Posted | Count of Participants | Participants | 6 months after the start of enrollment |
|
|
|
| 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. | This subsample of participants is based on study arm and woman's HIV status. | Posted | Count of Participants | Participants | In the first two months of enrollment |
|
|
|
| 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 | Data reported for all participants with a follow-up visit within 90 days of randomization | Posted | Count of Participants | Participants | Enrollment - 30 days post enrollment of study participant |
|
|
|
|
| 1 |
| 58 |
| 1 |
| 58 |
| 0 |
| 58 |
| EG001 | HIV-Positive Control | Single strategy for partner HIV testing Standard partner notification services. | 0 | 58 | 0 | 58 | 0 | 58 |
| EG002 | 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. | 0 | 105 | 0 | 105 | 0 | 105 |
| EG003 | HIV-Negative Control | Single strategy for partner HIV testing Partner notification services adapted for partners of HIV-negative women. | 0 | 105 | 0 | 105 | 0 | 105 |
|
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| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |
| Male |
|
| Superiority |
The calculation of risk differences between study arms was originally planned. However, the linear-binomial model did not converge because of zero events in the intervention arm. |
|
| Feasibility of HIV self-testing for HIV-negative women |
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| Acceptability of HIV self-testing |
|
| Risk Difference (RD) |
| 23.3 |
| 2-Sided |
| 95 |
| 10.7 |
| 36.0 |
The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm |
| Superiority |