HIVMP3 PilotNCT04124536

Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women

A study testing HIV self-testing with partner notification. in people with HIV, run by University of North Carolina, Chapel Hill at 1 site in Zambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: HIV
What is being tested?: HIV self-testing with partner notification.
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 341 participants
Where: 1 siteZambia
Study dates: 3 Sep 2019to 7 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Zambia1 site

Chipata Health Centre
Lusaka

Other trials in Zambia

About this study

Official title: Z 31901 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women: A Pilot Study

Read the 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.

Conditions: HIV
Being tested: HIV self-testing with partner notification.
Keywords: Self Testing, Partner notification, Secondary Distribution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HIV self-testing with partner notification.Behavioural
HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm, regardless of HIV status.

Study groups in NCT04124536
Study group	Role	What they receive
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. Receives: Behavioral: HIV self-testing with partner notification.
Control	No intervention	Standard partner notification services, regardless of HIV status.

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Enrollment - 30 days post enrollment of study participant

Secondary outcomes (4)

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.
Measured: Enrollment - 30 days post enrollment of study participant
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.
Measured: 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.
Measured: 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.
Measured: In the first two months of enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 20197 Sep 2020

First posted11 Oct 2019
Study start3 Sep 2019
Primary completion3 Jul 2020
Study completion7 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 341 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04124536
Sponsor's protocol ID: 19-0276
Other IDs: R01AI131060
Acronym: MP3 Pilot
Status last verified: Apr 2021
First submitted: 9 Oct 2019
Last updated: 21 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 34735862

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Z 31901 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women: A Pilot Study
ClinicalTrials.gov ID: NCT04124536
Acronym / sponsor ID: MP3 Pilot / 19-0276
Conditions: HIV
Keywords: Self Testing, Partner notification, Secondary Distribution
Study type: Interventional
Recruitment status: Completed
Enrolment: 341 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 3 Sep 2019 (actual)
Primary completion: 3 Jul 2020 (actual)
Study completion: 7 Sep 2020 (actual)
First posted: 11 Oct 2019 (actual)
Results: Posted 24 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Pregnant women 18 years of age or older who enter antenatal care at Chipata Level 1 Hospital in Lusaka, Zambia will participate.

A random sample of women and health care workers will also participate in qualitative interviews.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: HIV self-testing with partner notification.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.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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, regardless of HIV status.	Behavioural	Intervention

Primary outcome

Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility
Time frame: 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

4 secondary outcomes

Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare Facility
Time frame: Enrollment - 30 days post enrollment of study participant
Number of Participants Reporting Social Harms
Time frame: Enrollment - 30 days post enrollment of study participant
Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative)
Time frame: 6 months after the start of enrollment
Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative)
Time frame: In the first two months of enrollment

Results and safety

Results posted to the registry on 24 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HIV-Positive Intervention	58	47
HIV-Positive Control	58	53
HIV-Negative Intervention	105	102
HIV-Negative Control	105	98
Healthcare Workers	15	15

Primary outcome: Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility

Time frame: Enrollment - 30 days post enrollment of study participant. Count of participants. Unit: Participants

Measure	HIV-Positive Intervention n = 47	HIV-Positive Control n = 53	HIV-Negative Intervention n = 102	HIV-Negative Control n = 98
Value	3	15	3	33

HIV-Positive Intervention vs HIV-Positive Control: Risk Difference (RD): -21.9 (95% CI -35.9 to -7.9)
HIV-Negative Intervention vs HIV-Negative Control: Risk Difference (RD): -30.7 (95% CI -40.6 to -20.8)

Population analysed: Data reported for all participants with a follow-up visit within 90 days of randomization

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From study enrollment through follow-up, a total of approximately 30 -90 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIV-Positive Intervention	1 of 58 (1.7%)	0 of 58 (0%)	1 of 58
HIV-Positive Control	0 of 58 (0%)	0 of 58 (0%)	0 of 58
HIV-Negative Intervention	0 of 105 (0%)	0 of 105 (0%)	0 of 105
HIV-Negative Control	0 of 105 (0%)	0 of 105 (0%)	0 of 105

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34735862Mutale 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.
Individual participant dataSharing planned: Yes. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ben Chi, MD principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HIV self-testing with partner notification. in people with HIV, run by University of North Carolina, Chapel Hill at 1 site in Zambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility (time frame: Enrollment - 30 days post enrollment of study participant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04124536, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.