N/A
N=2,160
Partners-based HIV Treatment for Couples Attending Antenatal Care
Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT03149237 ↗Enrolled (actual)
2,160
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Proportion of Time on Medication Among Pregnant Women — 0.67; 0.66 proportion of days with medicaiton
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Couples-based services (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Time on Medication Among Pregnant Women |
0.67; 0.66 | — |
| PRIMARY Proportion of Days With Medication Among Male Partner |
0.47; 0.55 | — |
Summary
The purpose of this R01 proposal is to evaluate the clinical impact, hypothesized mechanisms of behavior change, and cost-effectiveness of a partners-focused integrated elimination of mother-to-child transmission of HIV (EMTCT) package comprised of: 1) antenatal care-based couples HIV testing, ART enrollment, and care for sero-concordant HIV+ expectant couples; (2) Couples-based treatment in the post-partum period; (3) Couple-based education and skills building; and (4) Treatment continuity with the support of expert-patient (peer) supporters from couples who have successfully navigated EMTCT. This innovative approach to scaling up EMTCT services, if proven feasible and effective, will be adopted in President's Emergency Plan for AIDS Relief (PEPFAR) programs to accelerate progress toward EMTCT and helping families with HIV infection live long, healthy lives.
Eligibility Criteria
Inclusion Criteria
- Couples, one HIV+ pregnant woman and her infected male partner, will be eligible to participate if the woman's due date is >2 weeks from enrollment. Both persons must also be 18 years or older, able to give consent, willing to consent to an infant record search, and must agree to enroll in ART together.
Exclusion Criteria
- Couples will not be eligible to participate in the study if the woman is not pregnant, if both persons are not HIV+, if either person is younger than 18 years, if one member of the couple is unwilling to enroll in ART or consent to the infant record search, or if one member of the couple is unable to give consent due to mental limitations.
Data sourced from ClinicalTrials.gov (NCT03149237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.