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CompletedNCT03100643N'GageUpdated May 7, 2020

Development of a Couple-Based Mobile Health Intervention for Enhancing HIV Care Engagement Outcomes (N'Gage)

An observational study in HIV/AIDS, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-07.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
46
Sex
Male
01

Study 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.

Read the detailed description

Compared to other racial/ethnic groups in the US, Black men who have sex with men (MSM), once diagnosed, are less likely to be optimally engaged in HIV care and treatment. This undermines the promise of prevention approaches for reducing the disproportionate effects of HIV/AIDS on Black communities, emphasizing the urgency for increased research focus and intervention development. Understanding HIV care engagement in the context of the dyad may be part of a comprehensive effort to addressing multilevel influences on HIV care engagement that are unique to HIV+ Black MSM towards achieving the maximum public health benefit of treatment-as-prevention. However, the scarcity of dyad-level research limits our understanding of dyadic effects HIV care engagement to inform intervention development. Mobile technology-based strategies (mHealth) offer tremendous potential as an acceptable, feasible, and effective intervention approach for enhancing HIV care engagement among partnered HIV+ Black MSM for several important reasons: (1) Black MSM are likely to report having a primary partner and to participate in couple-based HIV interventions; (2) couple-based behavior (e.g., daily routines of the couple), within-partnership dynamics (e.g., trust, intimacy), and couple serostatus (i.e., serodiscordant and concordant-positive relationships) are understudied factors in optimal HIV care engagement among MSM; and (3) mHealth has shown feasibility and acceptability in targeting couple-based behavior (e.g., money management, family planning) in the general population. Moreover, mHealth offers potential in addressing social and structural barriers often experienced by Black MSM in accessing and engaging in HIV care. Therefore, the aims of the study are to: (Aim 1) examine mobile technology use and relational factors involved in HIV care engagement within the context of couples among HIV+ Black MSM; (Aim 2) synthesize Aim 1 findings to identify intervention targets for behavioral change and to derive a framework of an intervention to enhance HIV care engagement in a dyadic context; and (Aim 3) develop a novel, mobile technology product for enhancing HIV care engagement in the context of couples among HIV+ Black MSM. The end goal of the application is the development of a novel, theory-based, user-centered mHealth product that targets relationship factors and dynamics important in optimal HIV care engagement among HIV+ Black men in same-sex relationships. Through these aims, I will acquire additional training necessary for my career development in (a) theory and research methods (qualitative research methods and dyadic analysis) for conducting couple-based research, (b) formative research in intervention development using group model building, and (c) mHealth product development. These research and career development activities will build the foundation to my becoming an independent, NIH-funded investigator with skills to conduct couple-based intervention research using mobile health innovations that is part of a comprehensive effort in HIV prevention integrating advances in mobile technology and behavioral medicine to reduce racial/ethnic disparities in HIV.

02

Conditions studied

  • HIV/AIDS

Keywords

  • HIV/AIDS, mHealth, intervention development, African American men
03

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 46 is below the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • None.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
46 participants (actual)
Patient registry
No

Interventions

  • OthermHealth N'Gage mobile application

    To enhance HIV care engagement among couples using mobile technology.

06

What researchers measure

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.

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

07

Study locations

1 site
  • University of California San Francisco
    San Francisco, California 94158, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03100643
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Apr 4, 2017
Start date
Aug 1, 2015
Primary completion
Jan 31, 2020
Completion
Jan 31, 2020
Last update
May 7, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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