Trial Outcomes & Findings for Partners-based HIV Treatment for Couples Attending Antenatal Care (NCT NCT03149237)

Last Updated: 2023-08-21

Results Overview

Specifically, every patient is given 30 days to pick up their medication, with a grace period of 5 days. If a patient picks up medication more than 35 days from their last pick-up, then they will be considered not on their medication from day 30 until the day of their next pick-up, at which time they will be assumed to be on medication again; this will be calculated over the course of the one-year follow-up.

Recruitment status

COMPLETED

Study phase

Target enrollment

2160 participants

Primary outcome timeframe

12 months

Results posted on

2023-08-21

Participant Flow

Enrollment was conducted at 24 health facilities in Mozambique. It began in November of 2017 and was completed in December 2020

Unit of analysis: 24

Participant milestones

Participant milestones
Measure	Standard of Care The 12 clinics randomized to the control arm will continue to provide standard of care (SOC) EMTCT services that include: standard HoPS male engagement (male invitation to ANC services and couples HIV testing), opt-out rapid HIV testing of all pregnant women attending ANC, HIV-specific counseling and support for all women who test positive, provision of cotrimoxazole prophylaxis, and universal ART, as per option B+ guidelines.	Couples-based Services The 12 clinics randomly assigned to the intervention arm will receive a combination of community and clinical EMTCT services, including: (1) ANC-based couples HIV testing, couples-based treatment enrollment, and clinical care for sero-concordant HIV+ expectant couples; (2) couple-centered treatment in the post-partum period at the EID clinic; (3) couples-based education and skills building during the ANC and post-partum period; and (4) treatment continuity support by expert-patient (peer) navigators selected among couples who have successfully navigated EMTCT. Couples-based services: Couples-based services, including treatment, counseling and peer mentoring in the community.
Overall Study STARTED	1108 12	1052 12
Overall Study COMPLETED	1104 12	1047 12
Overall Study NOT COMPLETED	4 0	5 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard of Care The 12 clinics randomized to the control arm will continue to provide standard of care (SOC) EMTCT services that include: standard HoPS male engagement (male invitation to ANC services and couples HIV testing), opt-out rapid HIV testing of all pregnant women attending ANC, HIV-specific counseling and support for all women who test positive, provision of cotrimoxazole prophylaxis, and universal ART, as per option B+ guidelines.	Couples-based Services The 12 clinics randomly assigned to the intervention arm will receive a combination of community and clinical EMTCT services, including: (1) ANC-based couples HIV testing, couples-based treatment enrollment, and clinical care for sero-concordant HIV+ expectant couples; (2) couple-centered treatment in the post-partum period at the EID clinic; (3) couples-based education and skills building during the ANC and post-partum period; and (4) treatment continuity support by expert-patient (peer) navigators selected among couples who have successfully navigated EMTCT. Couples-based services: Couples-based services, including treatment, counseling and peer mentoring in the community.
Overall Study Withdrawal by Subject	4	5

Baseline Characteristics

Partners-based HIV Treatment for Couples Attending Antenatal Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care n=1104 Participants The 12 clinics randomized to the control arm will continue to provide standard of care (SOC) EMTCT services that include: standard HoPS male engagement (male invitation to ANC services and couples HIV testing), opt-out rapid HIV testing of all pregnant women attending ANC, HIV-specific counseling and support for all women who test positive, provision of cotrimoxazole prophylaxis, and universal ART, as per option B+ guidelines.	Couples-based Services n=1047 Participants The 12 clinics randomly assigned to the intervention arm will receive a combination of community and clinical EMTCT services, including: (1) ANC-based couples HIV testing, couples-based treatment enrollment, and clinical care for sero-concordant HIV+ expectant couples; (2) couple-centered treatment in the post-partum period at the EID clinic; (3) couples-based education and skills building during the ANC and post-partum period; and (4) treatment continuity support by expert-patient (peer) navigators selected among couples who have successfully navigated EMTCT. Couples-based services: Couples-based services, including treatment, counseling and peer mentoring in the community.	Total n=2151 Participants Total of all reporting groups
Age, Continuous	26.4 years STANDARD_DEVIATION 5.9 • n=5 Participants	26.2 years STANDARD_DEVIATION 5.8 • n=7 Participants	26.3 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	552 Participants n=5 Participants	525 Participants n=7 Participants	1077 Participants n=5 Participants
Sex: Female, Male Male	552 Participants n=5 Participants	522 Participants n=7 Participants	1074 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1104 Participants n=5 Participants	1047 Participants n=7 Participants	2151 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Mozambique	1104 participants n=5 Participants	1047 participants n=7 Participants	2151 participants n=5 Participants
Education None	188 Participants n=5 Participants	120 Participants n=7 Participants	308 Participants n=5 Participants
Education Some/completed primary	717 Participants n=5 Participants	726 Participants n=7 Participants	1443 Participants n=5 Participants
Education more than primary	199 Participants n=5 Participants	201 Participants n=7 Participants	400 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: This is the primary analysis among women

Outcome measures

Outcome measures
Measure	Standard of Care n=552 Participants The 12 clinics randomized to the control arm will continue to provide standard of care (SOC) EMTCT services that include: standard HoPS male engagement (male invitation to ANC services and couples HIV testing), opt-out rapid HIV testing of all pregnant women attending ANC, HIV-specific counseling and support for all women who test positive, provision of cotrimoxazole prophylaxis, and universal ART, as per option B+ guidelines.	Couples-based Services n=525 Participants The 12 clinics randomly assigned to the intervention arm will receive a combination of community and clinical EMTCT services, including: (1) ANC-based couples HIV testing, couples-based treatment enrollment, and clinical care for sero-concordant HIV+ expectant couples; (2) couple-centered treatment in the post-partum period at the EID clinic; (3) couples-based education and skills building during the ANC and post-partum period; and (4) treatment continuity support by expert-patient (peer) navigators selected among couples who have successfully navigated EMTCT. Couples-based services: Couples-based services, including treatment, counseling and peer mentoring in the community.
Proportion of Time on Medication Among Pregnant Women	0.67 proportion of days with medicaiton Standard Deviation 0.26	0.66 proportion of days with medicaiton Standard Deviation 0.27

PRIMARY outcome

Timeframe: 12 months

Proportion of days with medication (based on date of pick up and the number of pills provided by the pharmacy) among male partners

Outcome measures

Outcome measures
Measure	Standard of Care n=552 Participants The 12 clinics randomized to the control arm will continue to provide standard of care (SOC) EMTCT services that include: standard HoPS male engagement (male invitation to ANC services and couples HIV testing), opt-out rapid HIV testing of all pregnant women attending ANC, HIV-specific counseling and support for all women who test positive, provision of cotrimoxazole prophylaxis, and universal ART, as per option B+ guidelines.	Couples-based Services n=522 Participants The 12 clinics randomly assigned to the intervention arm will receive a combination of community and clinical EMTCT services, including: (1) ANC-based couples HIV testing, couples-based treatment enrollment, and clinical care for sero-concordant HIV+ expectant couples; (2) couple-centered treatment in the post-partum period at the EID clinic; (3) couples-based education and skills building during the ANC and post-partum period; and (4) treatment continuity support by expert-patient (peer) navigators selected among couples who have successfully navigated EMTCT. Couples-based services: Couples-based services, including treatment, counseling and peer mentoring in the community.
Proportion of Days With Medication Among Male Partner	0.47 proportion of days with medicaiton Standard Deviation 0.31	0.55 proportion of days with medicaiton Standard Deviation 0.29

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 25 deaths

Couples-based Services

Serious events: 0 serious events

Other events: 0 other events

Deaths: 23 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carolyn Audet

Vanderbilt University Medical Center

Phone: 615-343-2418

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place