Helping Men Have Healthy Babies

• ClinicalTrials.gov Identifier: NCT03818984
• Recruitment Status: Completed
• First Posted: January 28, 2019
• Last Update Posted: April 17, 2020
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Lynn T Matthews, University of Alabama at Birmingham

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
HIV/AIDS; HIV Prevention	Behavioral: Safer Conception for Men with At Risk Partners	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Men will be offered 3 safer conception counseling sessions plus 2 booster sessions
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Safer Conception for HIV-infected Men Choosing to Conceive With At-risk Partners: Sinikithemba Kwabesilisa (Helping Men Have Healthy Babies)
• Actual Study Start Date: November 6, 2015
• Actual Primary Completion Date: October 25, 2017
• Actual Study Completion Date: October 25, 2017

Arms and Interventions

Arm

Intervention/treatment

Experimental: Safer Conception Intervention; Men will participate in 3 counseling sessions with a lay counselor. In the first session, the counselor will share information on the various safer conception strategies and help the participant think about developing a healthy plan. In the following 2 sessions, the counselor and the participant will work together to develop a healthy baby plan using motivational interviewing and problem solving. In the 2 booster sessions, the counselor and the participant will check in to evaluate the success of the plan and make changes as necessary.

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.

Outcome Measures

Primary Outcome Measures :

1. HIV RNA Suppression [ Time Frame: 12 weeks ]
   Proportion of men achieving HIV-RNA suppression

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 45 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Lynn T Matthews, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03818984
• Other Study ID Numbers: 2013P002693
• First Posted: January 28, 2019
• Last Update Posted: April 17, 2020
• Last Verified: April 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases