Getting to Zero: Safer Conception Programming Among HIV Sero-different Couples in Uganda

NCT03895619 | Completed

• 1 other identifier: 2018s0272
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Despite effective strategies to reduce periconception HIV transmission, there are few services to support people living with or affected by HIV to use these methods. In particular, there is a lack of safer conception services focused on engaging men living with HIV. Given known gender inequities in childbearing decision-making and HIV risk, it is critical that safer conception services deliver programming that engages men living with HIV and their HIV sero-different partners. The Healthy Families program, based at the ISS Clinic at Mbarara Regional Referral Hospital, offers client-centered safer conception care to help HIV-affected individuals and couples meet reproductive goals. This care supports clients to leverage personal motivations and partner and social supports to overcome structural barriers and use Antiretroviral Therapy (ART), adopt other HIV-prevention strategies, and remain in care. This pilot study (the 'Getting to Zero' study) will assess uptake and experiences of safer conception care among 50 men living with HIV and their HIV sero-different partners. Investigators will also assess men's retention in HIV care and HIV transmission risk to partners and infants. This is a one-year mixed-methods prospective pilot research study, which will use electronic chart review data, longitudinal survey data (from the male index and female partner participant), and qualitative data from in-depth semi-structured interviews to meet study objectives. By demonstrating safer conception uptake and impact on HIV transmission risks to partners and infants, investigators aim to inform HIV and reproductive health policy in Uganda and globally.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Number of HIV infected men and their female partners attending Safer Conception Counselling Sessions and choosing a safer conception strategy that meets their needs

  We will document the number of participants who return to their clinic with their female pregnancy partner to attend Safer Conception Counselling. We will also document the type of strategy chosen.

  1.5 year

Secondary Outcomes (5)

• Types of factors contributing to uptake of safer conception strategies among men living with HIV

  1.5 year

• Number of men living with HIV retained in care who are part of the safer conception intervention.

  1.5 year

• HIV transmission incidence among HIV-affected individuals and couples where the male partner is living with HIV and engaged in the safer conception intervention.

  1.5 year

• Periconception HIV transmission incidence among HIV-affected individuals and couples.

  1.5 year

• HIV incidence among female partners of men living with HIV engaged in the safer conception intervention.

  1.5 year

Study Arms (1)

Men living with HIV

EXPERIMENTAL

Uptake of safer conception strategies among men living with HIV and/or their female partners

Other: Safer conception strategies

Interventions

Safer conception strategies OTHER

Individuals and couples adopt safer conception strategies including HIV-serostatus disclosure to partner, ART uptake and adherence and HIV-RNA suppression, STI testing and treatment, timing condomless sex to peak fertility, partner ARV use (ART if living with HIV, PrEP if HIV negative), and contraception until ready to conceive.

Men living with HIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For enrollment in the Getting to Zero study, eligibility criteria for the index participant include the following:
• Identify as male
• HIV-positive
• Report personal or partner desire to have a child in the next year
• Identified pregnancy partner is reported to be HIV-negative or he doesn't know her HIV serostatus.
• Aged 18 years or older.
• Be naïve to the Healthy Families program.
• Live within 60km of the ISS clinic and not planning to relocate to an area incompatible with an ability to attend the clinic over a 1 year follow-up period.
• Able and willing to participate in the informed consent process.
• Identify as a partner of an enrolled male Getting to Zero participant
• Aged 18 years or older
• Able and willing to participate in the informed consent process.
• These participants will be referred to as the "partner". If the female partner is identified as HIV-positive after the male index participant enrolls in the Getting to Zero study, both partners remain eligible to participate.

You may not qualify if:

• Identify as female
• HIV-negative
• Does not report personal or partner desire to have a child in the next year
• Identified pregnancy partner is reported to be HIV-positive
• Under age 18 years.
• Be a patient of the Healthy Families program.
• Live greater than 60km of the ISS clinic and planning to relocate to an area incompatible with attending the clinic over a 1 year follow-up period.
• Unable and unwilling to participate in the informed consent process.

Sponsors & Collaborators

• Simon Fraser University: lead
• Mbarara University of Science and Technology: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Immune Suppression Syndrome (ISS) Clinic at the Mbarara Regional Referral Hospital (MRRH)

Mbarara, Uganda

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Proof of Concept Research

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: March 29, 2019
• Study Start: November 26, 2018
• Primary Completion: September 26, 2019
• Study Completion: October 31, 2019
• Last Updated: April 17, 2020

Record last verified: 2020-04

Locations

UG (1)