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| ID | Type | Description | Link |
|---|---|---|---|
| R34AA030489 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| San Diego State University | OTHER |
| Makerere University | OTHER |
| University of California, San Diego |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kisoboka Mukwano Intervention (treatment) | Experimental | 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. |
|
| Screening & Referral (control) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kisoboka Mukwano ("It is possible, my love!") Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in antiretroviral therapy (ART) adherence biomarker (females and HIV+ male partners) | presence of Tenofoivir Disoproxil Fumarate (TDF) detected in urine | 3 and 6 month follow up |
| 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 | 3 and 6 month follow up |
| change from baseline in HIV care engagement (females and HIV+ male partners) | HIV clinic visit adherence | 3 months, 6 months |
| change from baseline in phosphatidylethanol (PEth) (male partners) | alcohol biomarker (PEth) levels | 6 months |
| change from baseline in heavy drinking (male partners) | assessed with the Alcohol Use Disorders Identification Test (AUDIT-C) | 3 months, 6 months |
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in HIV viral load (females and HIV+ males) | (1) Biomarker testing using blood (females) and (2) clinic records (males). | 6 months |
| change from baseline in PrEP adherence (male partners taking PrEP) |
Inclusion Criteria
Adolescent girls and young women (AGYW)/Female:
Male Partners of AGYW/Male:
Couples (each partner (male and female) must independently report):
Exclusion Criteria
AGYW (female):
Couples (male and female):
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| Name | Affiliation | Role |
|---|---|---|
| Ijeoma Nwabuzor Ogbonnaya, PhD | Arizona State University | Principal Investigator |
| Susan M Kiene, PhD | San Diego State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Makerere Univerisity School of Public Health | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41207472 | Derived | Nwabuzor Ogbonnaya I, Nakigudde J, Naigino R, Stockman JK, Chung Y, Nantongo M, Marsiglia FF, Hahn JA, Wechsberg WM, Mwebembezi A, Wanyenze RK, Kiene SM. Protocol for the Kisoboka Mukwano pilot randomized controlled trial in Uganda: A couples-based intervention to reduce intimate partner violence and alcohol use among adolescent girls and young women living with HIV and their male partners. Contemp Clin Trials. 2025 Dec;159:108136. doi: 10.1016/j.cct.2025.108136. Epub 2025 Nov 7. |
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All collected individual participant data (IPD) that underlie the 6-month clinical trial, excluding qualitative data and data collected for formative research.
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.
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).
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 8, 2025 | Aug 26, 2025 |
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| OTHER |
| Reach the Youth Uganda | OTHER |
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| Screening and Referral | Behavioral | Intimate partner violence screening, alcohol screening, and referral |
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self- report of missed PrEP using an adapted version of the AIDS Clinical Trials Group Adherence (AACTG) measures
| 3 and 6 month follow up |
| PrEP uptake | Initiation of PrEP | through 6 month follow-up |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D008403 | Mass Screening |
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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