Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+)
About the Study
The purpose of this randomized clinical trial (RCT) is to test the effectiveness of CHAMPS+ comprised of the combination of a Community Health Worker (CHW) and mobile health (mHealth) intervention as compared to standard of care.
This is an in-person trial and includes screening, baseline assessment, and 6- and 12-month follow-up assessments. Study visits will take place in selected clinics in Jackson (MS), Hobson City and Opelika (AL), and New Orleans (LA). The procedures in this study are to complete surveys and blood draws every six months after enrollment. Participants will be randomly assigned to one of two groups. Some participants will receive a pill bottle dispenser with access to a mobile application (app) and 10 information sessions lead by a community health worker, while other participants will receive a standard of care.
The time frame for your involvement in the study is one year. Study participants will receive up to USD$150 after finishing the study.
For Participants
- To achieve the Ending the HIV Epidemic: A Plan for America, better strategies are needed to promote antiretroviral (ART) adherence and viral suppression in persons living with HIV (PWH) from health disparity populations to engage them in HIV care and to reduce HIV risk behaviors during periods of non-suppression. In response, our study team has developed and demonstrated evidence for components of the CHAMPS+ intervention which will promote ART adherence and suppressed viral load for PWH who live in the Deep South (Alabama, Mississippi, and New Orleans), a geographic area of the US with high rates of new HIV infections and PWH who are virally unsuppressed.
- List inclusion criteria:
- Able to speak, read, and write in English.
- Aged ≥18 years.
- Willing to participate in any assigned arm of the intervention.
- Having been diagnosed with HIV ≥6 months ago.
- Have an HIV-1 RNA level >200 copies/mL.
- viral load >50.
- ART adherence <80% as measured through Single-Item Self-Rating Adherence Scale (SRSI).
- Own a smartphone.
- Ability and willingness to provide informed consent for study participation and consent for access to medical records.
- Fill out our screener survey to see if you’re eligible!
Benefits
There may be no direct benefit to you for participating in this study. Although it cannot be guaranteed, you may benefit from improved self-management of your HIV by being in this study.
Alternative Procedures
The alternative is not to participate. You are free to refuse to participate or to withdraw from this research at any time.
Confidentiality
Any information collected during this study that can identify you by name will be kept confidential. We will do everything we can to keep your data secure.
Voluntary Participation
Participation in this research is voluntary. You are free to decline to be in this study, or to withdraw from it at any point.
For Researchers
- The purpose of this Randomized Clinical Trial (RCT) is to test the effectiveness of CHAMPS+ comprised of the combination of a Community Health Worker (CHW) and mobile health (mHealth) intervention as compared to standard of care.
- Study duration: 1 year.