Trial Outcomes & Findings for Leveraging mHealth and Peers to Engage African- Americans and Latinxs in HIV Care (LEAN) (NCT NCT03934437)

NCT ID: NCT03934437

Last Updated: 2024-11-22

Results Overview

Viral Suppression defined as a viral load \< 200 copies/cc

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 451 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2024-11-22

Participant Flow

Participant milestones

Measure	mLTCR The mLTCR intervention consists of two smartphone applications (app), one for patients and one for patient supporters, to help facilitate communication. mLTCR: mHealth-enhanced Linkage to Care and Retention	LTCR Existing linkage to care and retention (LTCR) services which are standard-of-care LTCR: Linkage and Retention Services (Standard-of-Care)
Overall Study STARTED	225	226
Overall Study COMPLETED	223	225
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Leveraging mHealth and Peers to Engage African- Americans and Latinxs in HIV Care (LEAN)

Baseline characteristics by cohort

Measure	mLTCR n=223 Participants The mLTCR intervention consists of two smartphone applications (app), one for patients and one for patient supporters, to help facilitate communication. mLTCR: mHealth-enhanced Linkage to Care and Retention	LTCR n=225 Participants Existing linkage to care and retention (LTCR) services which are standard-of-care LTCR: Linkage and Retention Services (Standard-of-Care)	Total n=448 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	210 Participants n=5 Participants	207 Participants n=7 Participants	417 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants
Age, Continuous	45.1 years n=5 Participants	45.0 years n=7 Participants	45.1 years n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants	73 Participants n=7 Participants	160 Participants n=5 Participants
Sex: Female, Male Male	136 Participants n=5 Participants	152 Participants n=7 Participants	288 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	173 Participants n=5 Participants	172 Participants n=7 Participants	345 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment United States	223 participants n=5 Participants	225 participants n=7 Participants	448 participants n=5 Participants
HIV Viral Load Suppression (Copies/cc) Undetectable (<200 copies/cc, well controlled)	112 Participants n=5 Participants	128 Participants n=7 Participants	240 Participants n=5 Participants
HIV Viral Load Suppression (Copies/cc) Detectable (>=200 copies/cc, poorly controlled)	93 Participants n=5 Participants	82 Participants n=7 Participants	175 Participants n=5 Participants
HIV Viral Load Suppression (Copies/cc) No VL (presumed poorly controlled)	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Two participants withdrew from mLTCR; one participant withdrew from LTCR.

Viral Suppression defined as a viral load < 200 copies/cc

Outcome measures

Measure	mLTCR n=223 Participants The mLTCR intervention consists of two smartphone applications (app), one for patients and one for patient supporters, to help facilitate communication. mLTCR: mHealth-enhanced Linkage to Care and Retention	LTCR n=225 Participants Existing linkage to care and retention (LTCR) services which are standard-of-care LTCR: Linkage and Retention Services (Standard-of-Care)
Participants With HIV Viral Load Suppression (Copies/cc) Undetectable (<200 copies/cc, well controlled)	114 Participants	128 Participants
Participants With HIV Viral Load Suppression (Copies/cc) Detectable (>=200 copies/cc, poorly controlled)	38 Participants	32 Participants
Participants With HIV Viral Load Suppression (Copies/cc) No VL (presumed poorly controlled)	71 Participants	65 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Two participants withdrew from mLTCR; one participant withdrew from LTCR.

Retained in care based upon viral load, CD4, OR clinic visit reported in enhanced HIV/AIDS Reporting System (eHARS)

Outcome measures

Measure	mLTCR n=223 Participants The mLTCR intervention consists of two smartphone applications (app), one for patients and one for patient supporters, to help facilitate communication. mLTCR: mHealth-enhanced Linkage to Care and Retention	LTCR n=225 Participants Existing linkage to care and retention (LTCR) services which are standard-of-care LTCR: Linkage and Retention Services (Standard-of-Care)
Participants Retained in Care	152 Participants	160 Participants

Adverse Events

mLTCR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Linkage to Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 11 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Larry Chang

Johns Hopkins University

Phone: 4109551725

Email: lchang8@jh.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place