An interventional study of Community Health Worker in HIV/AIDS, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-23.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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Among 38 studies in Acquired Immunodeficiency Syndrome by Massachusetts General Hospital — 7 open to participants now, 8 under way, 1 of them phase 3. Acquired Immunodeficiency Syndrome · Massachusetts General Hospital.
Among the 38 studies in Acquired Immunodeficiency Syndrome by Massachusetts General Hospital, this one is the 15th largest by enrollment of the 31 interventional ones that give a count, is the only one that started in 2017, is one of 26 with no phase, and was the 16th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →7 of the 38 studies in Acquired Immunodeficiency Syndrome by Massachusetts General Hospital are open now, in 5 countries. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in Nigeria
Ages 16–29
Massachusetts General Hospital · Sites in United States
Ages 50+ · Healthy volunteers
Massachusetts General Hospital · Sites in Kenya
Ages 16–24 · Women only · Healthy volunteers
Massachusetts General Hospital · Sites in United States
Ages 18+
Massachusetts General Hospital · Sites in South Africa, Uganda
Ages 15+
By country, each count listing its studies:
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
38 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 4 · Phase 3 1 · Phase 4 1
First in 2001; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 67 is below the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 63 across the 31 interventional studies, 46 across the 7 observational. Of the 29 that completed or were terminated, 12 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
Massachusetts General Hospital is the lead sponsor of 2,589 studies on the registry; 447 are open to participants now.
Of its 223 completed or terminated interventional studies of FDA-regulated products, 168 (75%) have results posted.
3 of the studies in Acquired Immunodeficiency Syndrome by Massachusetts General Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06436274Massachusetts General HospitalEfficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV. | 2026-12 |
| NCT06274632Massachusetts General HospitalADELANTE: A Randomized Controlled Trial to Improve Engagement in Care for Latinos With HIV | 2027-02-28 |
| NCT05373758Massachusetts General HospitalA Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa | 2027-06-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 38 studies in Acquired Immunodeficiency Syndrome by Massachusetts General Hospital, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Overview:
Participants will be HIV-infected Hispanic immigrants age ≥18 years. Participants will be recruited from Partners-affiliated infectious disease and primary care clinics as well as clinics and community-based organizations in the Greater Boston area with high contact with HIV-infected Hispanics. In the intervention, a bilingual (English-Spanish speaking) community health worker (CHW) will deliver personalized sessions framed around a Spanish-language multi-media health communication tool. The CHW will deliver the intervention over a 16 to 24 week period.
Study procedures:
Participants will be HIV-infected Hispanic immigrants age ≥18 years at risk for inconsistent attendance (as measured during study screening). Participants will be recruited via provider referral, peer referral, flyers, and social media. Once an individual expresses interest in the study, a study staff member will screen that individual to assess eligibility. Individuals who are eligible will be invited to enroll through an informed consent process and complete a baseline survey. After completion of the baseline survey, study staff will randomize participants into a treatment as usual (TAU) group or intervention group. At trial exit, all participants, including the TAU group, will complete an in-depth assessment to measure their barriers to HIV care and provide feedback about their experience in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive bilingual written materials on healthy living with HIV at the baseline visit. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants.
Participants in the intervention arm will receive 5 one-on-one sessions over 24 weeks with a Spanish-speaking CHW. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants
Behavioral: Community Health Worker
Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.
Retention in Care - Yes Responses
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.
Time frame: 32 weeks
Number of Participants With HIV Viral Load Suppression up to Week-24
Participants with HIV viral load \<200 copies/ml
Time frame: From baseline to week-24
Change in CD4 T-cell Count Over 24 Weeks
Change in CD4 T-cell count from baseline to week-24 post-randomization
Time frame: From baseline to week-24
Number of Participants With HIV Viral Load Suppression up to 48 Weeks.
Number of participants with HIV RNA \<200 copies/ml
Time frame: Baseline to week-48
Change in CD4 T-cell Count Over 48 Weeks.
Change in CD4 T-cell count from baseline to week-48 post-randomization
Time frame: Baseline to week-48
| Milestone | Treatment as Usual | Community Health Worker |
|---|---|---|
| Started | 32 | 35 |
| Completed | 30 | 31 |
| Not completed | 2 | 4 |
| Withdrew: Lost to follow-up | 1 | 3 |
| Withdrew: Declined participation in exit assess | 1 | 1 |
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.
| Participants | Treatment as Usual | Community Health Worker |
|---|---|---|
| Retention in Care - Yes Responses | 19 | 23 |
Participants with HIV viral load \<200 copies/ml
| Participants | Treatment as Usual | Community Health Worker |
|---|---|---|
| Number of Participants With HIV Viral Load Suppression up to Week-24 | 30 | 31 |
Change in CD4 T-cell count from baseline to week-24 post-randomization
| 1000 cells/uL | Treatment as Usual | Community Health Worker |
|---|---|---|
| Change in CD4 T-cell Count Over 24 Weeks | 6.0 ± 174.8 | 25.7 ± 137.0 |
Number of participants with HIV RNA \<200 copies/ml
| Participants | Treatment as Usual | Community Health Worker |
|---|---|---|
| Number of Participants With HIV Viral Load Suppression up to 48 Weeks. | 27 | 26 |
Change in CD4 T-cell count from baseline to week-48 post-randomization
| 1000 cells/uL | Treatment as Usual | Community Health Worker |
|---|---|---|
| Change in CD4 T-cell Count Over 48 Weeks. | -2.4 ± 179.4 | 29.6 ± 184.6 |
Collected over through study completion up to 48 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment as Usual | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Community Health Worker | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
Data obtained from 67 participants who enrolled and completed baseline assessment
| Age, Customized(Participants) | Treatment as Usual | Community Health Worker | Total |
|---|---|---|---|
| 18-25 years | 1 | 3 | 4 |
| >=26 years | 31 | 32 | 63 |
| Sex: Female, Male(Participants) | Treatment as Usual | Community Health Worker | Total |
|---|---|---|---|
| Female | 10 | 18 | 28 |
| Male | 22 | 17 | 39 |
| Ethnicity (NIH/OMB)(Participants) | Treatment as Usual | Community Health Worker | Total |
|---|---|---|---|
| Hispanic or Latino | 32 | 35 | 67 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment as Usual | Community Health Worker | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 4 | 8 |
| White | 5 | 3 | 8 |
| More than one race | 19 | 22 | 41 |
| Unknown or Not Reported | 4 | 6 | 10 |
| HIV Viral suppression(Participants) | Treatment as Usual | Community Health Worker | Total |
|---|---|---|---|
| Count of participants | 27 | 31 | 58 |
| Baseline CD4 cell count(Participants) | Treatment as Usual | Community Health Worker | Total |
|---|---|---|---|
| 0-200 cells/mm^3 | 1 | 3 | 4 |
| 201-500 cells/mm^3 | 11 | 7 | 18 |
| >500 cells/mm^3 | 19 | 25 | 44 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2017 to primary completion in May 2019, 23 months.
Results were first posted in Dec 2022, 3 years 7 months after primary completion.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 23 months is below that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
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