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OpenTrials
Completed

NCT Number: NCT03818984

Helping Men Have Healthy Babies

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Identifies as male
  • Not on ART, or initiated ART within the past 3 months
  • HIV-positive and status known for at least 1 (one) month,
  • in care/patient at iThembalabantu clinic
  • want to have a child in the next year,
  • with a stable sexual pregnancy partner for at least 6 months,
  • their pregnancy partner should be HIV-uninfected or HIV-status unknown,
  • their pregnancy partner should not be known to be currently pregnant,
  • have their own/ a mobile phone
  • be fluent in either English or isiZulu and,
  • able to participate in informed consent process
  • not sterilized or known to be infertile

Treatment and study plan

Safer Conception for Men with At Risk Partners

Behavioral

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.

Primary outcomes

  1. HIV RNA Suppression

    Time frame: 12 weeks

    Proportion of men achieving HIV-RNA suppression

Secondary outcomes

  1. Uptake of ART

    Time frame: 12 weeks

    The proportion of men who initiate or continue ART

  2. Uptake of HIV-serostatus disclosure

    Time frame: 12 weeks

    The proportion of men who report disclosure of HIV serostatus to pregnancy partner

  3. Use of timing condomless sex to peak fertility

    Time frame: 12 weeks

    Through SMS surveys to assess weekly sexual behavior the study will evaluate the proportion of men who attempt to limit condomless sex to peak fertility

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 28, 2019
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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