PositiveLinks: mHealth for DC Cohort

NCT04998019 | Completed DMC

• 2 other identifiers: 2028291R01MH122375-01A1
• Study Type: interventional
• Target: 682
• Locations: 1 country
• Sites: 13

Brief Summary

To achieve the end of the HIV epidemic, concerted efforts will be needed to address the HIV care continuum, including improving retention in care (RIC) and viral suppression (VS) among persons with HIV (PWH). In the U.S., less than 50% of PWH are RIC and even fewer are VS. Studies have shown that these PWH have poorer clinical outcomes and are at risk of transmitting HIV to others, hence the need for innovative solutions to improve retention in care and subsequent viral suppression. Theory-based mHealth interventions have been shown to be promising in reaching these at-risk groups and improving HIV-related outcomes. PositiveLinks is a clinic-deployed mHealth platform that includes patient and provider smartphone apps, a web portal for clinic staff and providers to manage patient cohorts, an online implementation guide, and a learning management system to train and certify clinic staff. It has theory-based features including daily queries of adherence, mood, and stress, graphical feedback for self-monitoring, secure messaging with staff, appointment reminders, anonymized peer support, information resources, and document upload capability to support insurance re-enrollment. A 12-month prospective study in poorly retained PWH found that PL increased RIC and VS, with app use related to benefit as well as improved social support and stigma. PL is a promising existing mHealth tool for PWH, yet its efficacy has not been tested in a randomized trial, nor in urban populations. The investigators will test the efficacy of PositiveLinks to improve RIC and VS among a cohort of PWH in a high HIV prevalence city of Washington, DC. Participants will be identified from the DC Cohort, a longitudinal prospective cohort of PWH receiving HIV care at 15 clinics in DC. First, the investigators will conduct formative research to assess the feasibility, acceptability and usability of PositiveLinks among this urban cohort and conduct subsequent adaptations based on these findings. The investigators will then conduct an efficacy study through a cluster randomized controlled trial at 12 DC Cohort sites among 482 PWH. Clinics will be randomized to PL or usual care. Primary outcomes will include VS, RIC, and visit constancy at 12 months. Finally, the investigators will conduct mixed methods implementation science research guided by the Consolidated Framework for Implementation Research and RE-AIM to identify site, patient, provider, and system factors that characterize best practices in program implementation. If successful, this research will lead to the development of a novel and efficacious approach to improving RIC and VS among PWH which could lead to dissemination research that will contribute to HIV epidemic control. This project is responsive to NIH priorities, National HIV/AIDS Strategy, and Ending the HIV Epidemic goals as it is cross-cutting, seeks to reduce health inequities, and to improve health outcomes to achieve sustained viral suppression in a geographic hotspot for HIV.

Conditions

HIV/AIDS

Keywords

mobile Health; HIV care continuum; implementation science

Outcome Measures

Primary Outcomes (3)

• Viral Suppression

  Viral Suppression will be the nearest viral load measurement to the 12-month study time point for the participant, +/-90 days.

  Month 12 from baseline

• Retention in Care

  Retention in Care will be measured by Visit Constancy (i.e., proportion of 4-month time intervals with one visit with an HIV care provider completed in the 12-month time period of study participation)

  Month 12 from baseline

• Retention in Care

  Retention in Care will be measured by HRSA-1 (i.e.,keeping 2 HIV care appointments separated by 90 days within the 12-month time period of study participation)

  Month 12 from baseline

Study Arms (2)

PositiveLinks

EXPERIMENTAL

Participants from clinics randomized to PL will get the patient smartphone app; clinic staff will receive the provider portal and provider smartphone app, the provider online LMS (learning management system), and the research assistant will use the administrative website to enroll participants. Patients randomized to PL will use it for 12 months or more; they can opt to use it as long as it is available during the study(access depending on enrollment date).

Behavioral: PositiveLinks

Usual Care

NO INTERVENTION

Participants from clinics randomized to Usual Care (UC) will receive usual clinic retention and medication adherence support services for 12M. Based on site assessments, and descriptions from the clinics, the UC condition ranges from having no ancillary support to only case management, to Ryan White funding and comprehensive services (adherence support, patient navigation, mental health, substance abuse, dental services and food banks)

Interventions

PositiveLinks BEHAVIORAL

The PositiveLinks (PL) patient mobile app delivers appointment reminders, daily queries ("check-ins") of mood, stress and medication adherence, tailored educational resources, access to the PL team for individualized assistance, and the opportunity to interact with other users on a secure, anonymous community message board (CMB).

PositiveLinks

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• PLWH and eligible for/enrolled in DC Cohort study age 16 or older
• speaks and reads English or Spanish at 4th grade level or above
• can provide informed consent; if a minor, is in charge of own HIV care
• plans to reside in the DC metro area for the next 12M
• has at least one of the following indicators of poor retention (in order of priority):
• detectable virus,
• not retained in care,
• returning to care after a gap of ≥6 months, d) no visit constancy
• newly diagnosed or initiating HIV care
• recently transferred from a different HIV care site
• evidence of HIV care receipt at a DC Cohort site and a non-DC Cohort site based on the DOH (Department of Health) linkage(\~9%).

You may not qualify if:

• age below 16, or if patient is 16-17; parent is in charge of HIV care
• unable to provide legal, independent consent to participate
• PLWH receiving care at two DC Cohort sites (\~10%) will be excluded

Sponsors & Collaborators

• George Washington University: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Virginia: collaborator

Study Sites (13)

MetroHealth

Washington D.C., District of Columbia, 20005, United States

Location

Unity Medical Center

Washington D.C., District of Columbia, 20005, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

La Clinica Del Pueblo

Washington D.C., District of Columbia, 20009, United States

Location

Children's National Medical Center Pediatric Clinic

Washington D.C., District of Columbia, 20010, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Washington Health Institute

Washington D.C., District of Columbia, 20017, United States

Location

Family and Medical Counseling Service

Washington D.C., District of Columbia, 20020, United States

Location

Whitman-Walker Health

Washington D.C., District of Columbia, 20036, United States

Location

George Washington Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Howard University Hospital Adult Clinic

Washington D.C., District of Columbia, 20060, United States

Location

Howard University Hospital Pediatric Clinic

Washington D.C., District of Columbia, 20060, United States

Location

Veterans Affairs Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

Related Publications (22)

• Canan CE, Waselewski ME, Waldman ALD, Reynolds G, Flickinger TE, Cohn WF, Ingersoll K, Dillingham R. Long term impact of PositiveLinks: Clinic-deployed mobile technology to improve engagement with HIV care. PLoS One. 2020 Jan 6;15(1):e0226870. doi: 10.1371/journal.pone.0226870. eCollection 2020.

  PMID: 31905209 BACKGROUND

• Flickinger TE, DeBolt C, Xie A, Kosmacki A, Grabowski M, Waldman AL, Reynolds G, Conaway M, Cohn WF, Ingersoll K, Dillingham R. Addressing Stigma Through a Virtual Community for People Living with HIV: A Mixed Methods Study of the PositiveLinks Mobile Health Intervention. AIDS Behav. 2018 Oct;22(10):3395-3406. doi: 10.1007/s10461-018-2174-6.

  PMID: 29882048 BACKGROUND

• Laurence C, Wispelwey E, Flickinger TE, Grabowski M, Waldman AL, Plews-Ogan E, Debolt C, Reynolds G, Cohn W, Ingersoll K, Dillingham R. Development of PositiveLinks: A Mobile Phone App to Promote Linkage and Retention in Care for People With HIV. JMIR Form Res. 2019 Mar 20;3(1):e11578. doi: 10.2196/11578.

  PMID: 30892269 BACKGROUND

• Cohn WF, Canan CE, Knight S, Waldman AL, Dillingham R, Ingersoll K, Schexnayder J, Flickinger TE. An Implementation Strategy to Expand Mobile Health Use in HIV Care Settings: Rapid Evaluation Study Using the Consolidated Framework for Implementation Research. JMIR Mhealth Uhealth. 2021 Apr 28;9(4):e19163. doi: 10.2196/19163.

  PMID: 33908893 BACKGROUND

• Flickinger TE, DeBolt C, Waldman AL, Reynolds G, Cohn WF, Beach MC, Ingersoll K, Dillingham R. Social Support in a Virtual Community: Analysis of a Clinic-Affiliated Online Support Group for Persons Living with HIV/AIDS. AIDS Behav. 2017 Nov;21(11):3087-3099. doi: 10.1007/s10461-016-1587-3.

  PMID: 27766448 BACKGROUND

• Dillingham R, Ingersoll K, Flickinger TE, Waldman AL, Grabowski M, Laurence C, Wispelwey E, Reynolds G, Conaway M, Cohn WF. PositiveLinks: A Mobile Health Intervention for Retention in HIV Care and Clinical Outcomes with 12-Month Follow-Up. AIDS Patient Care STDS. 2018 Jun;32(6):241-250. doi: 10.1089/apc.2017.0303.

  PMID: 29851504 BACKGROUND

• Flickinger TE, Ingersoll K, Swoger S, Grabowski M, Dillingham R. Secure Messaging Through PositiveLinks: Examination of Electronic Communication in a Clinic-Affiliated Smartphone App for Patients Living with HIV. Telemed J E Health. 2020 Mar;26(3):359-364. doi: 10.1089/tmj.2018.0261. Epub 2019 Mar 21.

  PMID: 30900961 BACKGROUND

• Castel AD, Kalmin MM, Hart RL, Young HA, Hays H, Benator D, Kumar P, Elion R, Parenti D, Ruiz ME, Wood A, D'Angelo L, Rakhmanina N, Rana S, Bryant M, Hebou A, Fernandez R, Abbott S, Peterson J, Wood K, Subramanian T, Binkley J, Happ LP, Kharfen M, Masur H, Greenberg AE. Disparities in achieving and sustaining viral suppression among a large cohort of HIV-infected persons in care - Washington, DC. AIDS Care. 2016 Nov;28(11):1355-64. doi: 10.1080/09540121.2016.1189496. Epub 2016 Jun 13.

  PMID: 27297952 BACKGROUND

• Castel AD, Terzian A, Hart R, Rayeed N, Kalmin MM, Young H, Greenberg AE; DC Cohort Executive Committee. Use of national standards to monitor HIV care and treatment in a high prevalence city-Washington, DC. PLoS One. 2017 Oct 5;12(10):e0186036. doi: 10.1371/journal.pone.0186036. eCollection 2017.

  PMID: 28982127 BACKGROUND

• Greenberg AE, Hays H, Castel AD, Subramanian T, Happ LP, Jaurretche M, Binkley J, Kalmin MM, Wood K, Hart R; DC Cohort Executive Committee. Development of a large urban longitudinal HIV clinical cohort using a web-based platform to merge electronically and manually abstracted data from disparate medical record systems: technical challenges and innovative solutions. J Am Med Inform Assoc. 2016 May;23(3):635-43. doi: 10.1093/jamia/ocv176. Epub 2015 Dec 31.

  PMID: 26721732 BACKGROUND

• Simoni JM, Frick PA, Pantalone DW, Turner BJ. Antiretroviral adherence interventions: a review of current literature and ongoing studies. Top HIV Med. 2003 Nov-Dec;11(6):185-98.

  PMID: 14724327 BACKGROUND

• Amico KR, Harman JJ, Johnson BT. Efficacy of antiretroviral therapy adherence interventions: a research synthesis of trials, 1996 to 2004. J Acquir Immune Defic Syndr. 2006 Mar;41(3):285-97. doi: 10.1097/01.qai.0000197870.99196.ea.

  PMID: 16540929 BACKGROUND

• Carey JW, Carnes N, Schoua-Glusberg A, Kenward K, Gelaude D, Denson D, Gall E, Randall LA, Frew PM. Barriers and Facilitators for Clinical Care Engagement Among HIV-Positive African American and Latino Men Who Have Sex with Men. AIDS Patient Care STDS. 2018 May;32(5):191-201. doi: 10.1089/apc.2018.0018. Epub 2018 Apr 18.

  PMID: 29668307 BACKGROUND

• Crawford TN. Poor retention in care one-year after viral suppression: a significant predictor of viral rebound. AIDS Care. 2014;26(11):1393-9. doi: 10.1080/09540121.2014.920076. Epub 2014 May 21.

  PMID: 24848440 BACKGROUND

• Giordano TP, Gifford AL, White AC Jr, Suarez-Almazor ME, Rabeneck L, Hartman C, Backus LI, Mole LA, Morgan RO. Retention in care: a challenge to survival with HIV infection. Clin Infect Dis. 2007 Jun 1;44(11):1493-9. doi: 10.1086/516778. Epub 2007 Apr 23.

  PMID: 17479948 BACKGROUND

• Rana AI, van den Berg JJ, Lamy E, Beckwith CG. Using a Mobile Health Intervention to Support HIV Treatment Adherence and Retention Among Patients at Risk for Disengaging with Care. AIDS Patient Care STDS. 2016 Apr;30(4):178-84. doi: 10.1089/apc.2016.0025.

  PMID: 27028183 BACKGROUND

• Higa DH, Marks G, Crepaz N, Liau A, Lyles CM. Interventions to improve retention in HIV primary care: a systematic review of U.S. studies. Curr HIV/AIDS Rep. 2012 Dec;9(4):313-25. doi: 10.1007/s11904-012-0136-6.

  PMID: 22996171 BACKGROUND

• Ingersoll KS, Dillingham RA, Hettema JE, Conaway M, Freeman J, Reynolds G, Hosseinbor S. Pilot RCT of bidirectional text messaging for ART adherence among nonurban substance users with HIV. Health Psychol. 2015 Dec;34S(0):1305-15. doi: 10.1037/hea0000295.

  PMID: 26651472 BACKGROUND

• Amico KR. Evidence for Technology Interventions to Promote ART Adherence in Adult Populations: a Review of the Literature 2012-2015. Curr HIV/AIDS Rep. 2015 Dec;12(4):441-50. doi: 10.1007/s11904-015-0286-4.

  PMID: 26412085 BACKGROUND

• Cooper V, Clatworthy J, Whetham J, Consortium E. mHealth Interventions To Support Self-Management In HIV: A Systematic Review. Open AIDS J. 2017 Nov 21;11:119-132. doi: 10.2174/1874613601711010119. eCollection 2017.

  PMID: 29290888 BACKGROUND

• Bauermeister JA, Golinkoff JM, Muessig KE, Horvath KJ, Hightow-Weidman LB. Addressing engagement in technology-based behavioural HIV interventions through paradata metrics. Curr Opin HIV AIDS. 2017 Sep;12(5):442-446. doi: 10.1097/COH.0000000000000396.

  PMID: 28617711 BACKGROUND

• Hodges J, Caldwell S, Cohn W, Flickinger T, Waldman AL, Dillingham R, Castel A, Ingersoll K. Evaluation of the Implementation and Effectiveness of a Mobile Health Intervention to Improve Outcomes for People With HIV in the Washington, DC Cohort: Study Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2022 Apr 22;11(4):e37748. doi: 10.2196/37748.

  PMID: 35349466 DERIVED

Related Links

• PositiveLinks app

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Amanda D Castel, MD, MPH

  George Washington University

  PRINCIPAL INVESTIGATOR

• Karen Ingersoll, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology

Model Details: cluster randomized trial

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 10, 2021
• Study Start: December 12, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

US (13)