NCT03100643

Brief Summary

HIV/AIDS among Black men is a US public health crisis, emphasizing the urgency for increased research focus and intervention development. The overall objective of this application is to achieve a better understanding of the role that dyadic factors play in individual-level HIV care engagement outcomes among HIV-positive Black men in romantic relationships. The end goal is the development of an intervention that employs innovative mobile technology to target partnership dynamics that optimize outcomes in the HIV care continuum.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

4.5 years

First QC Date

March 21, 2017

Last Update Submit

May 5, 2020

Conditions

Keywords

HIV/AIDS, mHealth, intervention development, African American men

Outcome Measures

Primary Outcomes (1)

  • Qualitative interview data on how participants used and liked the mHealth intervention prototype.

    Outcome will be based on qualitative feedback on prototype design, e.g., the look and feel of the prototype, how often the participants interacted with the prototype features, and whether or not participants feel that the intervention would be useful or helpful in improving their engagement in HIV care.

    Outcomes will be measured after a two-week pilot period during the fourth year of the project.

Interventions

To enhance HIV care engagement among couples using mobile technology.

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identify as male.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV-positive African American sexual minority men in a primary relationship and their relationship partner.

You may qualify if:

  • Identifies as African American or Black
  • Identifies with and presents as male
  • Is currently in a committed romantic relationship
  • Is HIV-positive
  • Have access to a mobile phone that can access the Internet

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2017

First Posted

April 4, 2017

Study Start

August 1, 2015

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

May 7, 2020

Record last verified: 2020-05

Locations