HIV
Conditions
Keywords
prevention, retention, mHealth
Brief summary
Randomized controlled study that will evaluate the effect of a text message-based strategy to improve retention in HIV care.
Detailed description
This is a randomized controlled pilot study with a parallel 2-arm design. It will evaluate the effect of a text message-based strategy to improve retention in HIV care at the study clinic, compared to the standard of care. Trained counselors will deliver the text messages. After a block randomization, the trained counselor (a nurse) will send the first welcoming message to participants in the intervention arm. The nurse will send 2 tailored text messages per week. In addition 2 to 4 days before an appointment, the nurse will send a message reminder. In addition, the nurse will have bilateral communication with participants using text messages according to their needs. The participants of the intervention arm will interact with the nurse during 3 months with a semi-structured strategy, that is, with template text messages (predesigned) and open messages (for which the nurse will be trained). Three and six months after started the intervention the variables of interest will be assessed.
Interventions
BEHAVIORALTailored text messages to improve retention in HIV care
Trained counselors will deliver the text messages. After a block randomization, the trained counselor (a nurse) will send the first welcoming message to participants in the intervention arm. The nurse will send 2 tailored text messages per week. In addition 2 to 4 days before an appointment, the nurse will send a message reminder. In addition, the nurse will have bilateral communication with participants using text messages according to their needs. The participants of the intervention arm will interact with the nurse during 3 months with a semi-structured strategy, that is, with template text messages (predesigned) and open messages (for which the nurse will be trained). Three and six months after started the intervention the variables of interest will be assessed.
Sponsors
NGO Via Libre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Masking description
After consenting, participants will be randomly assigned to the intervention or control with a 1:1 ratio and random block sizes of 2 and 4 using computer generated random numbers. Block sizes will not be disclosed. Allocations will be sealed in individual, sequentially numbered opaque envelopes. The RECRUITER, who will be masked to the group assignment, will give instructions to all participants on how they should interact if they start receiving SMS. After completing the baseline survey, one of the principal investigators will assign the participant to a group by opening the corresponding envelope. The PI will report to one of trained providers in charge of delivering the intervention (different from recruiters) when a new participant of the intervention arm is enrolled. Because of the nature of the participation, providers and participants will not be masked to group assignment.
Intervention model description
Randomized controlled pilot study with a parallel 2-arm design.The intervention arm will receive 2 tailored text messages weekly from a trained counselor during 3 months. The control arm will receive the standard of care, which consists of pre and post counseling after the HIV diagnosis and referral to a health facility to start antiretroviral treatment.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male 18 years old or older. * Linked to HIV care at the study clinic. * Have a cell phone. * Diagnosed at the study clinic of referred from other center to start ART. * Give consent to participate.
Exclusion criteria
* Enrolled in other HIV study using text messages. * Have started ART. * Enrolled in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention in timely monitoring of viral load (VL) | 6 months | Rate of participants with a second lab result of VL available 6 months after initiation of ART, verified using lab records |
Other
| Measure | Time frame | Description |
|---|---|---|
| Retention in HIV care | 3 months | Rate of participants who attended the 2nd and 3rd appointments for HIV care at the study clinic, verified using medical records |
Countries
Peru
Contacts
Primary ContactRobinson Cabello, MD
Backup ContactLuis Menacho, MD, MPH
Outcome results
None listed