NCT03484117: ADELANTE

Retention in HIV Care for Hispanic Immigrants

Completed NA Results posted Last updated 23 December 2022

What this trial tests

NA trial testing Community Health Worker in HIV/AIDS in 67 participants. Completed in 1 May 2019.

Timeline

26 May 2017

Primary endpoint
1 May 2019

1 May 2019

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	67
Start date	26 May 2017
Primary completion	1 May 2019
Estimated completion	1 May 2019
Sites	1 location across United States

Drugs / interventions tested

• Community Health Worker

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Retention in Care - Yes Responses Primary · 32 weeks

A dichotomized outcome (yes/no) with yes defined as at least one visit to HIV clinic at both time periods (week 1-16 and week 17-32), and no defined as no HIV visit from at least one time period. Responses determined by review of the medical record for evidence of attended HIV clinic visits.

Group	Value	95% CI
Treatment as Usual	19
Community Health Worker	23

Number of Participants With HIV Viral Load Suppression up to Week-24 Secondary · From baseline to week-24

Participants with HIV viral load \<200 copies/ml

Group	Value	95% CI
Treatment as Usual	30
Community Health Worker	31

Change in CD4 T-cell Count Over 24 Weeks Secondary · From baseline to week-24

Change in CD4 T-cell count from baseline to week-24 post-randomization

Group	Value	95% CI
Treatment as Usual	6.0	± 174.8
Community Health Worker	25.7	± 137.0

Number of Participants With HIV Viral Load Suppression up to 48 Weeks. Secondary · Baseline to week-48

Number of participants with HIV RNA \<200 copies/ml

Group	Value	95% CI
Treatment as Usual	27
Community Health Worker	26

Change in CD4 T-cell Count Over 48 Weeks. Secondary · Baseline to week-48

Change in CD4 T-cell count from baseline to week-48 post-randomization

Group	Value	95% CI
Treatment as Usual	-2.4	± 179.4
Community Health Worker	29.6	± 184.6

Sponsor's own description

A randomized trial to test the feasibility and acceptability of an intervention to improve retention in HIV primary care in HIV-infected Hispanic immigrants compared to a "treatment as usual" condition. We will measure feasibility, acceptability, study retention, and effect sizes of outcomes in order to inform a larger trial. The intervention design is based on qualitative research with HIV-infected Hispanic immigrants and their HIV providers. The intervention will be led by a Spanish-speaking community health worker trained in HIV health promotion.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.