Developing an HIV Disclosure Intervention for Men in Uganda
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HIV disclosure intervention.
- Who it may be relevant to
- Registry conditions: HIV Infections, Sexually Transmitted Infections (Not HIV or Hepatitis). Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Uganda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Assessment of an HIV Disclosure Intervention for Men in Uganda
Overview
The goal of this clinical trial is to test an HIV disclosure intervention that the investigators are developing focused on men living with HIV in Uganda. The main questions the investigators are trying to answer is whether the HIV disclosure intervention the investigators develop will help men who receive this intervention to disclose their HIV status to a greater extent than men who receive standard care. Participants assigned to the intervention group will likely participate in the following: * Sexual health education * Cognitive behavioral therapy strategies * Problem-solving skills building * Motivational interviewing * Developing a personalized HIV disclosure plan * Communication skills building * Role-playing disclosure strategies
Interventions
- Behavioral HIV disclosure intervention
This will be a biobehavioral intervention focused on helping men with HIV to disclose their HIV status to a personal confidant inclusive with specific focus on sexual partners.
Primary outcome measures
- HIV disclosure intervention acceptability [Time frame: 6 months]
- HIV disclosure intervention feasibility [Time frame: 6 months]
Secondary outcome measures (3)
- Index participant-reported disclosure [Time frame: 6 months]
- Partner participant HIV study site/clinic testing and counseling [Time frame: 6 months]
- HIV viral suppression [Time frame: 6 months]
Eligibility criteria
For all 3 Aims, "index participants" inclusion criteria will include:
- men living with HIV
- with sexually transmitted infection symptoms (e.g., urethral discharge, genital lesions)
- either not accessing antiretroviral therapy (per self-report109 and/or clinic documentation) or accessing antiretroviral therapy without HIV viral suppression
- age ≥18 years,
- with at least one sexual partner in the past three months
Aims 2 and 3 have the additional inclusion criteria:
- men living with HIV without HIV disclosure to at least one partner.
In Aims 2 and 3, male participants will be encouraged to invite sexual partners for enrollment. These "partner participants" will have the following inclusion criteria:
- age ≥18 years
- partnered with an enrolled man who reports HIV disclosure or plans for HIV disclosure with study support
- referred by the male participant.
Exclusion criteria
- an inability to speak the local language (Runyankole) or English
- an inability to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Uganda · 1 center
- Mbarara University of Science and Technology — Mbarara
Identifiers
NCT: NCT05771519 · 2022P003409 · K23MH126771