HIV/AIDS
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCommunity Health Worker
Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.
Sponsors
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older and able to communicate in Spanish or English * Born in Puerto Rico or Spanish-speaking Latin American country * HIV-infected or HIV-positive * New HIV diagnosis or unable to regularly attend HIV primary care appointments
Exclusion criteria
* Unable to provide verbal consent due to unstable medical or psychiatric condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention in Care - Yes Responses | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With HIV Viral Load Suppression up to Week-24 | From baseline to week-24 | Participants with HIV viral load \<200 copies/ml |
| Change in CD4 T-cell Count Over 24 Weeks | From baseline to week-24 | Change in CD4 T-cell count from baseline to week-24 post-randomization |
| Number of Participants With HIV Viral Load Suppression up to 48 Weeks. | Baseline to week-48 | Number of participants with HIV RNA \<200 copies/ml |
| Change in CD4 T-cell Count Over 48 Weeks. | Baseline to week-48 | Change in CD4 T-cell count from baseline to week-48 post-randomization |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment as Usual 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. | 32 |
| Community Health Worker 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
Community Health Worker: Participants will receive 5 one-on-one sessions with a CHW over 24 weeks. | 35 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Declined participation in exit assess | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | Total | Community Health Worker | Treatment as Usual |
|---|---|---|---|
| Age, Customized 18-25 years | 4 Participants | 3 Participants | 1 Participants |
| Age, Customized >=26 years | 63 Participants | 32 Participants | 31 Participants |
| Baseline CD4 cell count 0-200 cells/mm^3 | 4 Participants | 3 Participants | 1 Participants |
| Baseline CD4 cell count 201-500 cells/mm^3 | 18 Participants | 7 Participants | 11 Participants |
| Baseline CD4 cell count >500 cells/mm^3 | 44 Participants | 25 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 67 Participants | 35 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| HIV Viral suppression | 58 Participants | 31 Participants | 27 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 41 Participants | 22 Participants | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) White | 8 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Female | 28 Participants | 18 Participants | 10 Participants |
| Sex: Female, Male Male | 39 Participants | 17 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 35 |
| other Total, other adverse events | 0 / 32 | 0 / 35 |
| serious Total, serious adverse events | 0 / 32 | 0 / 35 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment as Usual | Retention in Care - Yes Responses | 19 Participants |
| Community Health Worker | Retention in Care - Yes Responses | 23 Participants |
Secondary
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
Population: CD4 count laboratory data at week-24 available for 66 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Change in CD4 T-cell Count Over 24 Weeks | 6.0 1000 cells/uL | Standard Deviation 174.8 |
| Community Health Worker | Change in CD4 T-cell Count Over 24 Weeks | 25.7 1000 cells/uL | Standard Deviation 137 |
Secondary
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
Population: CD4 count laboratory data at week-48 available for 59 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Change in CD4 T-cell Count Over 48 Weeks. | -2.4 1000 cells/uL | Standard Deviation 179.4 |
| Community Health Worker | Change in CD4 T-cell Count Over 48 Weeks. | 29.6 1000 cells/uL | Standard Deviation 184.6 |
Secondary
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
Population: HIV viral load laboratory data at week-48 available for 59 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment as Usual | Number of Participants With HIV Viral Load Suppression up to 48 Weeks. | 27 Participants |
| Community Health Worker | Number of Participants With HIV Viral Load Suppression up to 48 Weeks. | 26 Participants |
Secondary
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
Population: HIV viral load laboratory data at week-24 available for a total of 66 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment as Usual | Number of Participants With HIV Viral Load Suppression up to Week-24 | 30 Participants |
| Community Health Worker | Number of Participants With HIV Viral Load Suppression up to Week-24 | 31 Participants |