NCT03818984

Helping Men Have Healthy Babies

Safer Conception for HIV-infected Men Choosing to Conceive With At-risk Partners: Sinikithemba Kwabesilisa (Helping Men Have Healthy Babies)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Many men living with HIV (MLWH) want to have children. HIV-RNA suppression can minimize sexual HIV transmission risks while allowing for conception. The study will evaluate a safer conception intervention that leverages men's motivations to have healthy babies in order to promote serostatus disclosure and early ART initiation. The intervention is based on the investigators' Safer Conception Conceptual Framework, which considers individual, dyadic, and structural factors that affect periconception risk behavior.

Detailed description

The study will evaluate and test a safer conception intervention that leverages men's motivations to have healthy babies in order to promote serostatus disclosure and early ART initiation. The intervention is based on a Safer Conception Conceptual Framework, which considers individual, dyadic, and structural factors that affect periconception risk behavior. The researchers will conduct an open pilot to refine the intervention. The study will enroll men who want to have children with uninfected or unknown status female partners. Men will participate in three study sessions offering motivational interviewing and problem solving to help men develop a plan to have a healthy baby. The counseling will explore safer conception options including safe disclosure, delaying conception attempts until on ART with viral suppression, STI testing and treatment, timing condomless sex to peak fertility. The primary outcome is HIV RNA suppression at 12 weeks. Secondary outcomes include acceptability, feasibility, early ART uptake, adherence, serostatus disclosure, couples HIV counseling and testing uptake, and limiting unprotected sex to peak fertility.

Conditions

• HIV/AIDS
• HIV Prevention

Interventions

Type	Name	Description
BEHAVIORAL	Safer Conception for Men with At Risk Partners	CBT based safer conception counseling with longitudinal follow-up and booster sessions. The primary outcome will be HIV RNA suppression at 6 months. Secondary outcomes include early ART uptake, adherence, serostatus disclosure, couples HIV counseling and testing uptake, and limiting unprotected sex to peak fertility.

Timeline

• Start date: 2015-11-06
• Primary completion: 2017-10-25
• Completion: 2017-10-25
• First posted: 2019-01-28
• Last updated: 2020-04-17