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

This study is currently recruiting participants.
Verified March 2017 by University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT03100643
First Posted: April 4, 2017
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
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.

Condition Intervention
HIV/AIDS Other: mHealth N'Gage mobile application

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Development of a Couple-Based Mobile Health Intervention for Enhancing HIV Care Engagement Outcomes (N'Gage)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Qualitative interview data on how participants used and liked the mHealth intervention prototype. [ Time Frame: Outcomes will be measured after a two-week pilot period during the fourth year of the project. ]
    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.


Estimated Enrollment: 85
Actual Study Start Date: August 1, 2015
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: mHealth N'Gage mobile application
    To enhance HIV care engagement among couples using mobile technology.
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identify as 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.
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100643


Contacts
Contact: Judy Tan, PhD 415-476-6052 judy.tan@ucsf.edu
Contact: Bob Siedle-Khan 415-802-4500 bsiedle-khan@ucsf.edu

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Judy Tan, PhD    415-476-6052    judy.tan@ucsf.edu   
Principal Investigator: Judy Tan, PhD         
Sponsors and Collaborators
University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03100643     History of Changes
Other Study ID Numbers: 5K01MH106416-02 ( U.S. NIH Grant/Contract )
First Submitted: March 21, 2017
First Posted: April 4, 2017
Last Update Posted: April 4, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
HIV/AIDS, mHealth, intervention development, African American men