Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women (MP3 Pilot)

University of North Carolina (UNC)

Status: Completed

Conditions: HIV

Treatments: Behavioral: HIV self-testing with partner notification.

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04124536

R01AI131060 (U.S. NIH Grant/Contract)

19-0276

Details and patient eligibility

About

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

Full 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.

Enrollment: 341 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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341 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: HIV self-testing with partner notification.

Control

No Intervention group

Description:

Standard partner notification services, regardless of HIV status.