Partners-based HIV Treatment for Couples Attending Antenatal Care

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    3240
  • sponsor
    Vanderbilt University Medical Center
Updated on 19 March 2021
HIV Infection
hiv test
AIDS
HIV Vaccine
prenatal care
mother-to-child transmission

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.

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 Sade" (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 Zambzia 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.

Details
Condition HIV, HIV infection, HIV (Pediatric), HIV Infections, human immunodeficiency virus, hiv disease
Treatment Couples-based services
Clinical Study IdentifierNCT03149237
SponsorVanderbilt University Medical Center
Last Modified on19 March 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note