Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23MH126771 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Mbarara University of Science and Technology | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV disclosure intervention | Experimental | Participants assigned to the intervention group will likely participate in the following:
|
|
| Control | No Intervention | Participants assigned to the control group will likely participate in educational topics related to healthy living for men living with HIV. Procedures in both arms will encompass 3-5 individual sessions lasting 30-60 minutes over 2-3 months. There may also be a booster session at approximately the six-month timepoint. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV disclosure intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HIV disclosure intervention acceptability | Of 35 intervention participants, ≥70% (25 participants) rate all 4 items on the Acceptability of Intervention Measure (a 5-point Likert scales) as "agree" or higher. I will also assess intervention acceptability through qualitative interviews with participants and counselors. | 6 months |
| HIV disclosure intervention feasibility | Feasibility is defined by the Feasibility of Intervention Measure, intervention fidelity, and session completion. A) Feasibility of Intervention Measure: Of 35 intervention participants, ≥70% (25 participants) rate all 4 items on the Feasibility of Intervention Measure (a 5-point Likert scale) as "agree" or higher, B) Fidelity: Assuming a five-session intervention with 25% English-transcribed (44/175 sessions), intervention fidelity is attained when ≥70% (31 sessions) achieve ≥90% fidelity to the protocol adherence checklist, C) Session completion: Of the 35 intervention participants, ≥70% attend ≥50% of sessions. I will also assess intervention acceptability through qualitative interviews with participants and counselors. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Index participant-reported disclosure | Index participant-reported disclosure (measured by an expanded disclosure measurement tool and a Center For AIDS Research-funded HIV Disclosure Processes Model Measurement Scale in development. | 6 months |
| Partner participant HIV study site/clinic testing and counseling |
Not provided
For all 3 Aims, "index participants" inclusion criteria will include:
Aims 2 and 3 have the additional inclusion criteria:
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:
Exclusion Criteria:
All index participants will self-identify as male. Partner participants who men disclose to and bring into the study can be either male or female.
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pooja Chitneni, MD | Contact | 563-650-2245 | pchitneni@mgh.harvard.edu | |
| Jessica Haberer, MD | Contact | 408-605-3500 | jhaberer@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Pooja Chitneni, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mbarara University of Science and Technology | Mbarara | Uganda |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D012749 | Sexually Transmitted Diseases |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators will measure the percentage of partners that participants bring to clinic for HIV testing. |
| 6 months |
| HIV viral suppression | Participant HIV viral suppression measured by nucleic acid amplification testing. | 6 months |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |