An interventional study of Couples-based services in Human Immunodeficiency Virus, sponsored by Vanderbilt University Medical Center. Completed at 1 site in Mozambique. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Supportive care
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.
In severely resource-limited rural settings, scale-up of services to eliminate mother-to-child transmission of HIV (EMTCT) has failed to provide effective HIV testing and antiretroviral therapy (ART) coverage for women in highest prevalence southern African regions. All HIV-infected pregnant women are now eligible for life-long antiretroviral therapy (ART) (Option B+), but retention among women enrolled through Option B+ programs remains sub-optimal. In sub-Saharan Africa (SSA) it is common for women to require male partner approval to access and remain engaged in HIV-related health services. Despite the likelihood that male involvement would improve program coverage and adherence, the evidence base for effective interventions to involve male partners in HIV testing and treatment through antenatal care (ANC) point of care is very limited. Furthermore, whether such strategies are indeed cost-effective for improving outcomes of HIV-diagnosis and treatment in pregnancy is unknown. This proposal seeks to address these key gaps in the evidence base and guide scale-up by evaluating a promising male engagement intervention ("Homens para Saúde" (HoPS)+ [Men for Health]) targeting EMTCT in Mozambique through a clinic-randomized trial. This study will engage 24 ANC clinics; 12 intervention and 12 standard of care, with 45 HIV-infected couples per clinic where currently >60% of couples attend their first ANC visit together. The planned intervention addresses social-structural and cultural factors influencing EMTCT through the creation of couples-centered integrated HIV services, including: (1) ANC-based couples HIV testing, ART enrollment, and care for sero-concordant HIV+ expectant couples; (2) Couple-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. Given that 8.0% of all pregnant women and 7.2% of their partners tested HIV-positive during ANC visits in 2015 (FGH monitoring and evaluation [M\&E] data), the investigators pioneering work in Mozambique's rural Zambézia province suggests that innovative strategies are essential to engaging HIV-infected male partners in antenatal care (ANC) in order to achieve EMTCT and to improve substantially the health of the mothers. This team of Mozambican and U.S. investigators has a proven record of international HIV research success and they have specific recent experience with EMTCT cluster randomized trials, male-engagement in ANC services, and cost-effectiveness analysis of HIV programs. The specific aims of this study are: (1) To implement and evaluate the impact of male-engaged, couples-centered services on retention in care, adherence to ART, and early infant diagnosis among HIV+ pregnant women and their HIV+ male partners through a cluster-randomized control trial (RCT); (2) To investigate the impact of HoPS+ on hypothesized mechanisms of change; and (3) To use validated simulation models to evaluate cost-effectiveness of the HoPS+ intervention with the use of programmatic provincial monitoring and evaluation data and data from the trial results.
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This study's enrollment of 2,160 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
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Exclusion Criteria:
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.
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.
Behavioral: Couples-based services
Couples-based services, including treatment, counseling and peer mentoring in the community.
Proportion of Time on Medication Among Pregnant Women
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.
Time frame: 12 months
Proportion of Days With Medication Among Male Partner
Proportion of days with medication (based on date of pick up and the number of pills provided by the pharmacy) among male partners
Time frame: 12 months
Enrollment was conducted at 24 health facilities in Mozambique. It began in November of 2017 and was completed in December 2020
| Milestone | Standard of Care | Couples-based Services |
|---|---|---|
| Started | 1108 | 1052 |
| Completed | 1104 | 1047 |
| Not completed | 4 | 5 |
| Withdrew: Withdrawal by subject | 4 | 5 |
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.
| proportion of days with medicaiton | Standard of Care | Couples-based Services |
|---|---|---|
| Proportion of Time on Medication Among Pregnant Women | 0.67 ± 0.26 | 0.66 ± 0.27 |
Proportion of days with medication (based on date of pick up and the number of pills provided by the pharmacy) among male partners
| proportion of days with medicaiton | Standard of Care | Couples-based Services |
|---|---|---|
| Proportion of Days With Medication Among Male Partner | 0.47 ± 0.31 | 0.55 ± 0.29 |
Collected over During the 18 months the individual was in the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | 25/1,104 (2.3%) | 0/1,104 (0%) | 0/1,104 (0%) |
| Couples-based Services | 23/1,047 (2.2%) | 0/1,047 (0%) | 0/1,047 (0%) |
| Age, Continuous(years) | Standard of Care | Couples-based Services | Total |
|---|---|---|---|
| Mean | 26.4 ± 5.9 | 26.2 ± 5.8 | 26.3 ± 5.9 |
| Sex: Female, Male(Participants) | Standard of Care | Couples-based Services | Total |
|---|---|---|---|
| Female | 552 | 525 | 1077 |
| Male | 552 | 522 | 1074 |
| Race (NIH/OMB)(Participants) | Standard of Care | Couples-based Services | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1104 | 1047 | 2151 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Standard of Care | Couples-based Services | Total |
|---|---|---|---|
| Mozambique | 1104 | 1047 | 2151 |
| Education(Participants) | Standard of Care | Couples-based Services | Total |
|---|---|---|---|
| None | 188 | 120 | 308 |
| Some/completed primary | 717 | 726 | 1443 |
| more than primary | 199 | 201 | 400 |
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Plan to share: No — After the study is completed and the results published, the investigators will upload de-identified data to ICPSR.
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Acquired Immunodeficiency Syndrome→
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