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Improving HIV Care Engagement Among Ugandan Adolescent Girls and Young Women: The Kisoboka Mukwano Intervention

Primary Purpose

HIV-infection/Aids, Intimate Partner Violence, Domestic Violence

Status
Recruiting
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Kisoboka Mukwano ("It is possible, my love!") Intervention
Screening and Referral
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-infection/Aids

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Adolescent girls and young women (AGYW)/Female: aged 18-24 or self-reported as emancipated minors aged 15-17, HIV+ meets one or more of the following non-engagement criteria: not currently enrolled in an HIV clinic (e.g., never enrolled, dropped out); not currently taking ART; missed 1 or more scheduled HIV care appointments requiring physical presence (e.g., viral load [VL] testing) in the last 12 months; < 90% ART adherence in the last 2 weeks; most recent VL>1000 or expected recent VL test results absent in clinic records despite initiating ART >6 months ago self-report a history of at least one incident of IPV (physical, sexual, and/or emotional) and/or controlling behavior ever perpetrated by their current male partner agree to let research staff contact their male partner. Male Partners of AGYW/Male: aged 18+ years or emancipated minors report consuming ≥ 6 drinks per occasion at least once or more in the prior 30 days or scores 4 or more on the AUDIT (Alcohol Use Disorders Identification Test)-C Couples (each partner (male and female) must independently report): married or living together as if married for ≥6 months planning to stay together for at least another 2 months (intervention period) lived in the Wakiso District area ≥3 months not planning to move from the area within the next 6 months respond similarly (not exact but close) to questions on the study-developed Couple Verification Screening Exclusion Criteria AGYW (female): reporting any severe physical IPV experienced in prior 3 months. Couples (male and female): do not speak Luganda or English do not feel they cannot safely participate in the study.

Sites / Locations

  • Makerere Univerisity School of Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kisoboka Mukwano Intervention (treatment)

Screening & Referral (control)

Arm Description

A brief couples-based intervention using motivational interviewing, peer navigation, and behavioral economic approaches to target intimate partner violence, alcohol use, and HIV care engagement.

Brief feedback on intimate partner violence and alcohol use (males), referrals for these conditions, and briefly discuss the importance of HIV care engagement and adherence.

Outcomes

Primary Outcome Measures

change from baseline in antiretroviral therapy (ART) adherence biomarker (females and HIV+ male partners)
presence of Tenofoivir Disoproxil Fumarate (TDF) detected in urine
change from baseline in self-reported antiretroviral therapy (ART) adherence (females and HIV+ male partners)
Self- report of missed ART using the AIDS Clinical Trials Group Adherence (AACTG) measures
change from baseline in HIV care engagement (females and HIV+ male partners)
HIV clinic visit adherence
change from baseline in phosphatidylethanol (PEth) (male partners)
alcohol biomarker (PEth) levels
change from baseline in heavy drinking (male partners)
assessed with the Alcohol Use Disorders Identification Test (AUDIT-C)
Intimate partner violence (IPV) occurence (males and females)
Any incident of IPV perpetration and victimization: physical, sexual, verbal/emotional, intimidation and/or controlling behavior measured using the World Health Organization (WHO) Instrument/ Demographic and Health Data (DHS) Domestic Violence Modules.

Secondary Outcome Measures

Fear of intimate partner violence (males and females)
Rating of how often one is afraid of their current spouse/partner measured using the WHO Instrument/ DHS Domestic Violence Modules.

Full Information

First Posted
March 22, 2023
Last Updated
August 4, 2023
Sponsor
Arizona State University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), San Diego State University, Makerere University, University of California, San Diego, Reach the Youth Uganda
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1. Study Identification

Unique Protocol Identification Number
NCT05947539
Brief Title
Improving HIV Care Engagement Among Ugandan Adolescent Girls and Young Women: The Kisoboka Mukwano Intervention
Official Title
Improving HIV Care Engagement Among Ugandan Adolescent Girls and Young Women Through Reductions in Male Partner Alcohol Use and Intimate Partner Violence Risk: The Kisoboka Mukwano Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), San Diego State University, Makerere University, University of California, San Diego, Reach the Youth Uganda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will develop and pilot test a couples-based intervention to help adolescent girls and young women living with HIV (WLHIV (15-24 years) living in Uganda access HIV care and improve the outcomes of their HIV treatment by targeting male partner alcohol use to reduce IPV risk.
Detailed Description
In Uganda, adolescent girls and young women (AGYW) are disproportionately affected by HIV and have poor viral suppression rates, increasing their risk of onward transmission. Intimate partner violence (IPV) is a major barrier to mitigating the impact of HIV among AGYW. AGYW living with HIV (AGYWLHIV) in sub-Saharan Africa (SSA) who have experienced IPV have worse medication adherence, viral suppression, and care engagement than those without IPV. Further, male partner alcohol use directly and indirectly increases IPV risk among AGYW in SSA. Thus, an intervention with components that address heavy alcohol use among male partners could decrease AGYW's IPV risk, especially in Uganda, which has the highest alcohol use per capita in SSA. Couples- based interventions have effectively reduced male partner alcohol use, relationship conflict IPV, and improved viral suppression and HIV care engagement; yet, none have been tailored to AGYWLHIV in SSA. The investigators propose to develop and pilot a couples-based intervention that focuses on improving HIV care engagement and ART adherence among AGYWLHIV by reducing heavy alcohol use among male partners and couple IPV risk. Additionally, the investigators will explore the intervention's effects on AGYW viral load for the additional key benefit of treatment as prevention. The study aims are to: 1) Adapt the behavioral components of a brief Motivational Interviewing (MI)-based alcohol intervention to create the proposed Kisoboka Mukwano ("It is possible, my love!") intervention. The intervention will promote strategies for reductions in male partner alcohol use, coping with relationship conflict and stress, changing norms that reduce IPV and support engagement in HIV care and ART adherence among AGYWLHIV, and, thereby, enhance future sustained viral suppression and benefits of treatment as prevention. The intervention will be adapted and tailored to be delivered with heterosexual couples, involve peer navigators, address IPV, and be developmentally appropriate for AGYWLHIV in Uganda. The investigators will develop and refine the intervention in collaboration with an intervention steering committee through: qualitative research with married/cohabiting AGYWLHIV, married/cohabiting men, and key informants and an initial pilot test with 6 couples. 2) The investigators will assess safety, acceptability, feasibility, and preliminary estimates of the potential for the intervention, as compared to the control group, to improve HIV, alcohol, and IPV outcomes. The investigators will examine preliminary effects on AGYW HIV care engagement, AGYW ART adherence, heavy alcohol use among male partners, and couple IPV risk and explore effects on AGYW viral load as well as intermediate outcomes related to intervention components. The investigators will assess these outcomes at baseline and then at 3- and 6-month follow-up. Study findings will be used to guide a subsequent R01 proposal to test the intervention in a larger clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-infection/Aids, Intimate Partner Violence, Domestic Violence, Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kisoboka Mukwano Intervention (treatment)
Arm Type
Experimental
Arm Description
A brief couples-based intervention using motivational interviewing, peer navigation, and behavioral economic approaches to target intimate partner violence, alcohol use, and HIV care engagement.
Arm Title
Screening & Referral (control)
Arm Type
Active Comparator
Arm Description
Brief feedback on intimate partner violence and alcohol use (males), referrals for these conditions, and briefly discuss the importance of HIV care engagement and adherence.
Intervention Type
Behavioral
Intervention Name(s)
Kisoboka Mukwano ("It is possible, my love!") Intervention
Intervention Description
The intervention consists of 5 bi-weekly sessions each lasting 60 to 90 minutes. It uses motivational interviewing, peer navigation, and behavioral economics to promote strategies for economic strengthening, reductions in male partner alcohol use, coping with relationship conflict and stress, changing norms that reduce intimate partner violence and support engagement in HIV care and antiretroviral therapy (ART) adherence among adolescent girls and young women living with HIV, and, thereby, enhances future sustained viral suppression and benefits of treatment as prevention.
Intervention Type
Behavioral
Intervention Name(s)
Screening and Referral
Intervention Description
Intimate partner violence screening, alcohol screening, and referral
Primary Outcome Measure Information:
Title
change from baseline in antiretroviral therapy (ART) adherence biomarker (females and HIV+ male partners)
Description
presence of Tenofoivir Disoproxil Fumarate (TDF) detected in urine
Time Frame
3 and 6 month follow up
Title
change from baseline in self-reported antiretroviral therapy (ART) adherence (females and HIV+ male partners)
Description
Self- report of missed ART using the AIDS Clinical Trials Group Adherence (AACTG) measures
Time Frame
3 and 6 month follow up
Title
change from baseline in HIV care engagement (females and HIV+ male partners)
Description
HIV clinic visit adherence
Time Frame
3 months, 6 months
Title
change from baseline in phosphatidylethanol (PEth) (male partners)
Description
alcohol biomarker (PEth) levels
Time Frame
6 months
Title
change from baseline in heavy drinking (male partners)
Description
assessed with the Alcohol Use Disorders Identification Test (AUDIT-C)
Time Frame
3 months, 6 months
Title
Intimate partner violence (IPV) occurence (males and females)
Description
Any incident of IPV perpetration and victimization: physical, sexual, verbal/emotional, intimidation and/or controlling behavior measured using the World Health Organization (WHO) Instrument/ Demographic and Health Data (DHS) Domestic Violence Modules.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fear of intimate partner violence (males and females)
Description
Rating of how often one is afraid of their current spouse/partner measured using the WHO Instrument/ DHS Domestic Violence Modules.
Time Frame
6 month follow up
Other Pre-specified Outcome Measures:
Title
change from baseline in HIV viral load (females and HIV+ males)
Description
(1) Biomarker testing using blood (females) and (2) clinic records (males).
Time Frame
6 months
Title
change from baseline in PrEP adherence (male partners taking PrEP)
Description
self- report of missed PrEP using an adapted version of the AIDS Clinical Trials Group Adherence (AACTG) measures
Time Frame
3 and 6 month follow up
Title
PrEP uptake
Description
Initiation of PrEP
Time Frame
through 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Adolescent girls and young women (AGYW)/Female: aged 18-24 or self-reported as emancipated minors aged 15-17, HIV+ meets one or more of the following non-engagement criteria: not currently enrolled in an HIV clinic (e.g., never enrolled, dropped out); not currently taking ART; missed 1 or more scheduled HIV care appointments requiring physical presence (e.g., viral load [VL] testing) in the last 12 months; < 90% ART adherence in the last 2 weeks; most recent VL>1000 or expected recent VL test results absent in clinic records despite initiating ART >6 months ago self-report a history of at least one incident of IPV (physical, sexual, and/or emotional) and/or controlling behavior ever perpetrated by their current male partner agree to let research staff contact their male partner. Male Partners of AGYW/Male: aged 18+ years or emancipated minors report consuming ≥ 6 drinks per occasion at least once or more in the prior 30 days or scores 4 or more on the AUDIT (Alcohol Use Disorders Identification Test)-C Couples (each partner (male and female) must independently report): married or living together as if married for ≥6 months planning to stay together for at least another 2 months (intervention period) lived in the Wakiso District area ≥3 months not planning to move from the area within the next 6 months respond similarly (not exact but close) to questions on the study-developed Couple Verification Screening Exclusion Criteria AGYW (female): reporting any severe physical IPV experienced in prior 3 months. Couples (male and female): do not speak Luganda or English do not feel they cannot safely participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janet Nakigudde, PhD
Phone
+256772407885
Email
janet.nakigudde@mak.ac.ug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ijeoma Nwabuzor Ogbonnaya, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan M Kiene, PhD
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makerere Univerisity School of Public Health
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Nakigudde, PhD
Phone
+256772407885
Email
janet.nakigudde@mak.ac.ug
First Name & Middle Initial & Last Name & Degree
Janet Nakigudde, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected individual participant data (IPD) that underlie the 6-month clinical trial, excluding qualitative data and data collected for formative research.
IPD Sharing Time Frame
Two years after the grant end date specified on the first Notice of Award (08-31-2025). Any subject-level data and the associated analyzed data used in a journal publication will be shared at the time of publication, even if the publication occurs before the two-year automatic share date.
IPD Sharing Access Criteria
Access to data for research purposes will be provided through the National Institute of Mental Health (NIMH) Data Archive (NDA) Data Access Committee (DAC). Investigators and institutions seeking data from NDA will be expected to meet data security measures and will be asked to submit a Data Use Certification, which is cosigned by the investigator and the designated Institutional Official(s) at the NIH-recognized sponsoring institution with a current Federal Wide Assurance (FWA).
IPD Sharing URL
https://nda.nih.gov/nda/standard-operating-procedures.html#sop4a

Learn more about this trial

Improving HIV Care Engagement Among Ugandan Adolescent Girls and Young Women: The Kisoboka Mukwano Intervention

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