Trial Outcomes & Findings for Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users (NCT NCT03584282)
NCT ID: NCT03584282
Last Updated: 2024-06-05
Results Overview
Self-reported likelihood to recommend the text messaging intervention, via survey response, among those who received the text messaging intervention (may have been in the Standard of care group or the Peer Navigation group). Only participants who received the text messaging intervention are included in the analysis group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
6 months
Results posted on
2024-06-05
Participant Flow
Participant milestones
| Measure |
Standard of Care/Text Messaging
Participants in this group will receive the standard of care the text messaging intervention.
Text Messaging: The text messaging intervention will send three text messages per day from a library. One will be a reminder to take PrEP, one will include PrEP information, and the third will have the content of the participant's choosing from categories of harm reduction messages and health information. Participants will also select the time period to receive these texts.
Study intervention groups changed over time - the original study design was a 2 x 2 factorial design with peer navigation, text messaging, both interventions, and standard of care arms. However, with slow enrollment, reports of text messaging being a possible barrier to enrollment, and a smaller anticipated effect compared to peer navigation, the intervention groups were collapsed to a comparison of peer navigation (whether or not text messaging was included) compared to standard of care.
|
Peer Navigation
Participants in this group will receive the peer navigator intervention.
Peer Navigation: The peer navigation intervention will provide support from a peer that is responsive to a participant's individualized needs. Peer support may include phone call reminders, help refilling PrEP prescriptions, transit assistance, or other referrals.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users
Baseline characteristics by cohort
| Measure |
Standard of Care/Text Messaging
n=12 Participants
Participants in this group will receive the standard of care the text messaging intervention.
Text Messaging: The text messaging intervention will send three text messages per day from a library. One will be a reminder to take PrEP, one will include PrEP information, and the third will have the content of the participant's choosing from categories of harm reduction messages and health information. Participants will also select the time period to receive these texts.
Study intervention groups changed over time - the original study design was a 2 x 2 factorial design with peer navigation, text messaging, both interventions, and standard of care arms. However, with slow enrollment, reports of text messaging being a possible barrier to enrollment, and a smaller anticipated effect compared to peer navigation, the intervention groups were collapsed to a comparison of peer navigation (whether or not text messaging was included) compared to standard of care.
|
Peer Navigation
n=9 Participants
Participants in this group will receive the peer navigator intervention.
Peer Navigation: The peer navigation intervention will provide support from a peer that is responsive to a participant's individualized needs. Peer support may include phone call reminders, help refilling PrEP prescriptions, transit assistance, or other referrals.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
n=99 Participants
|
33 years
n=107 Participants
|
35 years
n=206 Participants
|
|
Sex/Gender, Customized
cisgender man
|
10 participants
n=99 Participants
|
8 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Sex/Gender, Customized
transgender female
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Sex/Gender, Customized
Non-binary/genderqueer
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
10 participants
n=99 Participants
|
3 participants
n=107 Participants
|
13 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Self-reported likelihood to recommend the text messaging intervention, via survey response, among those who received the text messaging intervention (may have been in the Standard of care group or the Peer Navigation group). Only participants who received the text messaging intervention are included in the analysis group.
Self-reported likelihood to recommend the text messaging intervention, via survey response, among those who received the text messaging intervention (may have been in the Standard of care group or the Peer Navigation group). Only participants who received the text messaging intervention are included in the analysis group.
Outcome measures
| Measure |
Standard of Care/Text Messaging
n=3 Participants
Participants in this group will receive the standard of care the text messaging intervention.
Text Messaging: The text messaging intervention will send three text messages per day from a library. One will be a reminder to take PrEP, one will include PrEP information, and the third will have the content of the participant's choosing from categories of harm reduction messages and health information. Participants will also select the time period to receive these texts.
Study intervention groups changed over time - the original study design was a 2 x 2 factorial design with peer navigation, text messaging, both interventions, and standard of care arms. However, with slow enrollment, reports of text messaging being a possible barrier to enrollment, and a smaller anticipated effect compared to peer navigation, the intervention groups were collapsed to a comparison of peer navigation (whether or not text messaging was included) compared to standard of care.
|
Peer Navigation
n=3 Participants
Participants in this group will receive the peer navigator intervention. Some were also assigned text messaging.
Peer Navigation: The peer navigation intervention will provide support from a peer that is responsive to a participant's individualized needs. Peer support may include phone call reminders, help refilling PrEP prescriptions, transit assistance, or other referrals.
|
|---|---|---|
|
Acceptability of Text Messaging
Unlikely to Recommend
|
0 Participants
|
1 Participants
|
|
Acceptability of Text Messaging
Neither Unlikely nor Likely to Recommend
|
1 Participants
|
0 Participants
|
|
Acceptability of Text Messaging
Very Unlikely to Recommend
|
0 Participants
|
0 Participants
|
|
Acceptability of Text Messaging
Likely to Recommend
|
0 Participants
|
0 Participants
|
|
Acceptability of Text Messaging
Very Likely to Recommend
|
1 Participants
|
1 Participants
|
|
Acceptability of Text Messaging
Data Missing (e.g. Survey not completed, question left blank)
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Self-reported likelihood to recommend the peer navigation intervention, via survey response, among those who were assigned to the peer navigation group. Only participants who received the peer navigation intervention are included in the analysis group.
Self-reported likelihood to recommend the peer navigation intervention, via survey response, among those who were assigned to the peer navigation group. Only participants who received the peer navigation intervention are included in the analysis group.
Outcome measures
| Measure |
Standard of Care/Text Messaging
n=9 Participants
Participants in this group will receive the standard of care the text messaging intervention.
Text Messaging: The text messaging intervention will send three text messages per day from a library. One will be a reminder to take PrEP, one will include PrEP information, and the third will have the content of the participant's choosing from categories of harm reduction messages and health information. Participants will also select the time period to receive these texts.
Study intervention groups changed over time - the original study design was a 2 x 2 factorial design with peer navigation, text messaging, both interventions, and standard of care arms. However, with slow enrollment, reports of text messaging being a possible barrier to enrollment, and a smaller anticipated effect compared to peer navigation, the intervention groups were collapsed to a comparison of peer navigation (whether or not text messaging was included) compared to standard of care.
|
Peer Navigation
Participants in this group will receive the peer navigator intervention. Some were also assigned text messaging.
Peer Navigation: The peer navigation intervention will provide support from a peer that is responsive to a participant's individualized needs. Peer support may include phone call reminders, help refilling PrEP prescriptions, transit assistance, or other referrals.
|
|---|---|---|
|
Acceptability of Peer Navigation
Very Unlikely to Recommend
|
0 Participants
|
—
|
|
Acceptability of Peer Navigation
Unlikely to Recommend
|
0 Participants
|
—
|
|
Acceptability of Peer Navigation
Neither Unlikely nor Likely to Recommend
|
0 Participants
|
—
|
|
Acceptability of Peer Navigation
Likely to Recommend
|
1 Participants
|
—
|
|
Acceptability of Peer Navigation
Very Likely to Recommend
|
3 Participants
|
—
|
|
Acceptability of Peer Navigation
Data Missing (e.g. Survey not completed or question left blank)
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPersistence on PrEP comparing standard of care or text messaging vs peer navigation, as measured by whether the participant had returned to the clinic at 6 months follow up their DBS card collection.
Outcome measures
| Measure |
Standard of Care/Text Messaging
n=12 Participants
Participants in this group will receive the standard of care the text messaging intervention.
Text Messaging: The text messaging intervention will send three text messages per day from a library. One will be a reminder to take PrEP, one will include PrEP information, and the third will have the content of the participant's choosing from categories of harm reduction messages and health information. Participants will also select the time period to receive these texts.
Study intervention groups changed over time - the original study design was a 2 x 2 factorial design with peer navigation, text messaging, both interventions, and standard of care arms. However, with slow enrollment, reports of text messaging being a possible barrier to enrollment, and a smaller anticipated effect compared to peer navigation, the intervention groups were collapsed to a comparison of peer navigation (whether or not text messaging was included) compared to standard of care.
|
Peer Navigation
n=9 Participants
Participants in this group will receive the peer navigator intervention. Some were also assigned text messaging.
Peer Navigation: The peer navigation intervention will provide support from a peer that is responsive to a participant's individualized needs. Peer support may include phone call reminders, help refilling PrEP prescriptions, transit assistance, or other referrals.
|
|---|---|---|
|
PrEP Persistence
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPrEP adherence measured in dried blood spots comparing standard of care/text messaging vs peer navigation, as measured by the detection of tenofovir-diphosphate (TFV-DP) in DBS collected 6 months after study enrollment.
Outcome measures
| Measure |
Standard of Care/Text Messaging
n=12 Participants
Participants in this group will receive the standard of care the text messaging intervention.
Text Messaging: The text messaging intervention will send three text messages per day from a library. One will be a reminder to take PrEP, one will include PrEP information, and the third will have the content of the participant's choosing from categories of harm reduction messages and health information. Participants will also select the time period to receive these texts.
Study intervention groups changed over time - the original study design was a 2 x 2 factorial design with peer navigation, text messaging, both interventions, and standard of care arms. However, with slow enrollment, reports of text messaging being a possible barrier to enrollment, and a smaller anticipated effect compared to peer navigation, the intervention groups were collapsed to a comparison of peer navigation (whether or not text messaging was included) compared to standard of care.
|
Peer Navigation
n=9 Participants
Participants in this group will receive the peer navigator intervention. Some were also assigned text messaging.
Peer Navigation: The peer navigation intervention will provide support from a peer that is responsive to a participant's individualized needs. Peer support may include phone call reminders, help refilling PrEP prescriptions, transit assistance, or other referrals.
|
|---|---|---|
|
PrEP Adherence
2-3 doses/week
|
1 Participants
|
1 Participants
|
|
PrEP Adherence
4-6 doses/week
|
0 Participants
|
2 Participants
|
|
PrEP Adherence
7 doses/week
|
2 Participants
|
1 Participants
|
|
PrEP Adherence
No DBS collected
|
8 Participants
|
3 Participants
|
|
PrEP Adherence
BLQ
|
0 Participants
|
1 Participants
|
|
PrEP Adherence
<2 doses/week
|
1 Participants
|
1 Participants
|
Adverse Events
Standard of Care/Text Messaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peer Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Joanne Stekler, Primary Investigator
University of Washington
Phone: (206) 744-8312
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place