Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women (MP3 Pilot)
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|ClinicalTrials.gov Identifier: NCT04124536|
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: HIV self-testing with partner notification.||Not Applicable|
Pregnant women 18 years of age or older who enter antenatal care (ANC) 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 (SD-HIVST). 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||336 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Z 31901 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women: A Pilot Study|
|Actual Study Start Date :||September 3, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||March 2021|
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.
Behavioral: 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.
No Intervention: Control
Standard partner notification services, regardless of HIV status.
- Proportion of primary male partners who complete facility-based HTS by participant self-report [ Time Frame: Enrollment - 30 days post enrollment of study participant ]The number of male partners getting tested for HIV when presented with partner notification plus SD-HIVST will be compared to partner notification alone
- Proportion of couples (pregnant woman and partner) who receive facility-based HTS together. [ Time Frame: Enrollment - 30 days post enrollment of study participant ]The number of couples getting tested for HIV when presented with partner notification plus SD-HIVST will be compared to partner notification alone.
- Incidence of social harms [ Time Frame: Enrollment - 30 days post enrollment of study participant ]The rate of social harms and other adverse events associated with the HIV testing approaches
- Feasibility - Qualitative summaries of healthcare worker experiences from in-depth interviews [ Time Frame: 6 months after the start of enrollment ]Experiences with providing partner HIV testing, including patient preferences, perceived benefits and harms, and health systems burden
- Acceptability - Qualitative summaries of participant experience from in-depth interviews [ Time Frame: within 2 months of enrollment ]Experiences with partner HIV testing, including use of HIV self-test kits (intervention arm), and how it affected partner relationships
- HIV testing rates among secondary male partners [ Time Frame: Enrollment - 30 days post enrollment ]The number of secondary male partners getting HIV tested when presented with partner notification plus SD-HIVST will be compared to partner notification alone
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124536
|Contact: Margaret Kasaro||260 967 780 firstname.lastname@example.org|
|Chipata Health Centre||Recruiting|
|Contact: Kellie Freeborn 260 967 780 284 email@example.com|
|Principal Investigator:||Ben Chi, MD||University of North Carolina, Chapel Hill|