HIV Seropositivity Clinical Trial
Official title:
Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (Tele-B6)
The research team has developed an interventional group program for young men living with HIV and will be adapting it for telehealth delivery. The purpose of the study is to determine whether or not this program can help improve social connections and the health of young men in online delivery and evaluate its potential for implementation in a community setting. The study has three phases: (1) engaging a community advisory board to create and adapt the intervention for online delivery, (2) a randomized clinical trial of the online intervention, and (3) evaluation of the program for community implementation with our partner organization. Participants in the second phase of the study will meet with a study team member to discuss the research process and provide informed consent. The community organization employees will provide consent online prior to completion of a survey and indicate whether they consent to be contacted further for in-depth interviews.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 29 Years |
Eligibility | Inclusion Criteria: - Black race, inclusive of multiracial identities; male gender, inclusive of transgender men; - self-identification as gay, bisexual, or another non-heterosexual orientation, and/or any history of consensual anal or oral sex with men; - HIV-positive serostatus; - age 18-29 years inclusive; - residence in the Atlanta Metropolitan Statistical Area; - available and interested to meet for two hours weekly over a six-week period. Exclusion Criteria: - Age < 18 years or > 30 years - Unwilling or unable to provide written informed consent - Enrollment in one phase of the study is an exclusion criterion for enrollment in other phases |
Country | Name | City | State |
---|---|---|---|
United States | Grady Infectious Diseases Program Clinic | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in HIV viral load | The research team will review the electronic medical record (EMR) to abstract HIV viral load information | 0 and 6 months | |
Other | Rate of retention care | The research team will review the electronic medical record (EMR) to abstract data on missed appointments | 0 and 6 months | |
Primary | Acceptability | Qualitative interviews: Open-ended questions adapted from the original B6 exit interview guide.
*8-month timepoint only applies to waitlist control participants |
Study Exit (up to 8* months) | |
Primary | Change in the Acceptability Surveys | Post-session evaluation forms (adapted from original B6) after each group session.
*8-month timepoint only applies to waitlist control participants |
2, 4, 6, up to 8* months | |
Primary | Change in Recruitment Rates | Rates of participation from screened and eligible participants.
*8-month timepoint only applies to waitlist control participants |
2, 4, 6, up to 8* months | |
Primary | Change in retention | Attendance logs during each visit.
*8-month timepoint only applies to waitlist control participants |
2, 4, 6, up to 8* months | |
Primary | Change in the intervention fidelity | Review of the Structured intervention logs (adapted from original B6)
*8-month timepoint only applies to waitlist control participants |
2, 4, 6, up to 8* months | |
Primary | Safety (adverse events) | Review of Adverse event tracking forms
*8-month timepoint only applies to waitlist control participants |
During study participation up to 8* months | |
Secondary | Change in Perception of Structural Racism and Discrimination. | Participants will complete surveys measuring socioeconomic status, material resources scale. The material resources survey has 18 questions asking how often the participants' family needs are adequately met. There are six options (never=0; rarely=1; less than half of the time=w, about half of the time=3; more than half of the time=4; and always=5). The highest score means that needs are adequately met.
*8-month timepoint only applies to waitlist control participants |
0, 2, 4, 6, 8* months | |
Secondary | Change in Perception of discrimination | Participants will complete the Everyday Discrimination Scale at baseline and after each session. Each response is given a value according to the Likert scale ('never'=1 to 'almost everyday'=6). Responses are summed across items to produce a score ranging from 10 to 60. A higher score may indicate higher perception of discrimination.
*8-month timepoint only applies to waitlist control participants |
0, 2, 4, 6, up to 8* months | |
Secondary | Change in Perception of HIV stigma | Participants will complete the HIV stigma scale at baseline and after each session. This scale includes which includes 10 item stigma rated on a 5-point scale from "Strongly Disagree" to "Strongly Agree".
*8-month timepoint only applies to waitlist control participants |
0, 2, 4, 6, up to 8* months | |
Secondary | Change in Perception of internalized homonegativity inventory | Participants will complete the internalized homonegativity inventory at baseline and after each session.
This 26-item scale has four subscales: (a) Public Identification as Gay, (b) Perception of Stigma Associated with Being Gay, (c) Social Comfort with Gay Men, (d) Moral and Religious Acceptability of Being Gay. *8-month timepoint only applies to waitlist control participants |
0, 2, 4, 6, up to 8* months | |
Secondary | Qualitative description of intersectional stigma | Participants will be asked to complete surveys with open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.
*8-month timepoint only applies to waitlist control participants |
Exit of study (up to 8 months) | |
Secondary | Change in intersectional stigma | Participants will be asked to complete surveys with open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.
*8-month timepoint only applies to waitlist control participants |
Exit of study (up to 8 months) | |
Secondary | Change in logistical barriers | Participants will be asked to complete surveys and matched to Zipcode to derive neighborhood measures.
*8-month timepoint only applies to waitlist control participants |
0, 2, 4, 6, up to 8* months | |
Secondary | Qualitative description of logistical barriers | Participants will be asked to complete open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.
*8-month timepoint only applies to waitlist control participants |
Exit of study (up to 8 months) | |
Secondary | Changes in perception of individual resilience process: Identity Affirmation | Participants will complete the multidimensional model of black identity lesbian, gay, and bisexual identity scale,
*8-month timepoint only applies to waitlist control participants |
0, 2, 4, 6, up to 8* months | |
Secondary | Qualitative description individual resilience process: Identity Affirmation | Participants will be asked to complete open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.
*8-month timepoint only applies to waitlist control participants |
Exit of study (up to 8 months) | |
Secondary | Changes in the community resilience process: social capital | Participants will complete the personal social capital scale. A five-point Likert scale is used to assess these questions with 1 = none and 5 = all. A composite score will be derived by summarizing the item scores such that a higher score indicates a greater perceived collective efficacy.
*8-month timepoint only applies to waitlist control participants |
0, 2, 4, 6, up to 8* months | |
Secondary | Qualitative description of the community resilience process: social capital | Participants will be asked to complete open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.
*8-month timepoint only applies to waitlist control participants |
Exit of study (up to 8 months) | |
Secondary | Changes in the perception of minority stress: depression | Participants will complete the Studies Depression Scale (CES-D) survey. In scoring the CES-D, a value of 0, 1, 2, or 3 is assigned to a response depending upon whether the item is worded positively or negatively. The possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology.
*8-month timepoint only applies to waitlist control participants |
0, 2, 4, 6, up to 8* months | |
Secondary | Changes in the perception of minority stress: general well-being | Participants will complete the general well-being (GWB) survey. The General Well-Being Schedule (GWB) is designed to assess an individual's mental health or quality of life. The GWB consists of 18 items indicating subjective feelings of psychological well-being and distress. All of the items utilize the past month as the time frame of interest. The first 14 questions use a six-point rating scale that represents either intensity or frequency. The remaining items use a 0-10 rating scale that is anchored by adjectives. Because some items are reverse scored (items 1, 3, 6, 7, 9, 11, 15, and 16), 14 is subtracted from the total score, yielding a total possible range of scores from 0 to 110. Low scores represent greater distress. Proposed cutoffs representing three levels of distress are 0-60 (severe distress), 61-72 (moderate distress), and 73-110 (positive well-being).
*8-month timepoint only applies to waitlist control participants |
0, 2, 4, 6, up to 8* months | |
Secondary | Qualitative description of the minority stress | Participants will be asked to complete open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.
*8-month timepoint only applies to waitlist control participants |
Exit of study (up to 8 months) |
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