MedTrace Logo

Helping Men Have Healthy Babies

NCT03818984 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-04-17

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-06
Primary Completion
2017-10-25
Completion
2017-10-25

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03818984 on ClinicalTrials.gov