Human Immunodeficiency Virus
Conditions
Keywords
Mozambique, Couples-based services, HIV/AIDS, Ante-natal Care
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALCouples-based services
Couples-based services, including treatment, counseling and peer mentoring in the community.
Sponsors
National Institute of Mental Health (NIMH)
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The 12 clinics randomly assigned to the intervention arm will receive a combination of community and clinical 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; (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. The 12 clinics randomized to the control arm will continue to provide standard of care 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Time on Medication Among Pregnant Women | 12 months | 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 Medication Among Male Partner | 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 |
Countries
Mozambique
Participant flow
Recruitment details
Enrollment was conducted at 24 health facilities in Mozambique. It began in November of 2017 and was completed in December 2020
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,104 |
| 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. | 1,047 |
| Total | 2,151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Total | Standard of Care | Couples-based Services |
|---|---|---|---|
| Age, Continuous | 26.3 years STANDARD_DEVIATION 5.9 | 26.4 years STANDARD_DEVIATION 5.9 | 26.2 years STANDARD_DEVIATION 5.8 |
| Education more than primary | 400 Participants | 199 Participants | 201 Participants |
| Education None | 308 Participants | 188 Participants | 120 Participants |
| Education Some/completed primary | 1443 Participants | 717 Participants | 726 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2151 Participants | 1104 Participants | 1047 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Mozambique | 2151 participants | 1104 participants | 1047 participants |
| Sex: Female, Male Female | 1077 Participants | 552 Participants | 525 Participants |
| Sex: Female, Male Male | 1074 Participants | 552 Participants | 522 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 25 / 1,104 | 23 / 1,047 |
| other Total, other adverse events | 0 / 1,104 | 0 / 1,047 |
| serious Total, serious adverse events | 0 / 1,104 | 0 / 1,047 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Proportion of Days With Medication Among Male Partner | 0.47 proportion of days with medicaiton | Standard Deviation 0.31 |
| Couples-based Services | Proportion of Days With Medication Among Male Partner | 0.55 proportion of days with medicaiton | Standard Deviation 0.29 |
Primary
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
Population: This is the primary analysis among women
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Proportion of Time on Medication Among Pregnant Women | 0.67 proportion of days with medicaiton | Standard Deviation 0.26 |
| Couples-based Services | Proportion of Time on Medication Among Pregnant Women | 0.66 proportion of days with medicaiton | Standard Deviation 0.27 |