HIV/AIDS, Adherence, Medication, Drug Use
Conditions
Keywords
Pre-Exposure Prophylaxis (PrEP), Methamphetamine
Brief summary
Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine (meth)-users being at particularly high risk. Building on their preliminary work, the investigators will pilot text messaging and peer navigation interventions to support PrEP use among meth-using MSM/TG with potential to be cost-effective, scalable, and easily adaptable.
Detailed description
Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine (meth)-users being at particularly high risk. Despite apparent high levels of PrEP knowledge and exceptional insurance and medication coverage, few meth-users in Western WA have enrolled in local PrEP programs. The investigators' preliminary work with meth-using MSM/TG has identified both traditional barriers to PrEP and barriers specific for meth users, including competing priorities (e.g., getting high); lack of regularity in daily schedules leading to difficulties complying with appointments and medication adherence; and concomitant wellness and social concerns, notably depression and meth-related stigma. Additional work is needed to develop new strategies to increase PrEP uptake and support persistence and adherence among meth-using MSM/TG. Building on their preliminary work, the investigators will pilot text messaging and peer navigation interventions to support PrEP use among meth-using MSM/TG with potential to be cost-effective, scalable, and easily adaptable. The first, peer navigation, has been studied in ARV treatment and has been proposed for PrEP. The second, text messaging, has been shown to increase ARV and PrEP adherence.
Interventions
BEHAVIORALText 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.
BEHAVIORALPeer 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.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The investigators will randomly assign 10 participants to each arm: 1) standard of care, 2) text messaging only, 3) peer navigation only, and 4) text messaging and peer navigation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Meets the clinic's eligibility criteria for PrEP * 18 years of age or older * HIV-negative * Cisgender man or individual on the trans gender variant spectrum who has sex with men * Ability to understand, read, and speak English * Reports meth use in the past 3 months * Has a cell phone able to send and receive text messages
Exclusion criteria
* PrEP use in the prior month, * Discomfort or anxiety with regards to text messaging. * Has any circumstances that, based on the study staff's opinion, would preclude provision of informed consent, make participation unsafe, or make it unlikely the participant would be able to participate for 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Text Messaging | 6 months | 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. |
| Acceptability of Peer Navigation | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Persistence | 6 months | Persistence 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. |
| PrEP Adherence | 6 months | PrEP 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 9 |
| Total | 21 |
Baseline characteristics
| Characteristic | Standard of Care/Text Messaging | Total | Peer Navigation |
|---|---|---|---|
| Age, Continuous | 36 years | 35 years | 33 years |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants | 3 participants | 3 participants |
| Race/Ethnicity, Customized Multiracial | 2 participants | 4 participants | 2 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 10 participants | 13 participants | 3 participants |
| Sex/Gender, Customized cisgender man | 10 participants | 18 participants | 8 participants |
| Sex/Gender, Customized Non-binary/genderqueer | 1 participants | 1 participants | 0 participants |
| Sex/Gender, Customized transgender female | 1 participants | 2 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 9 |
| other Total, other adverse events | 0 / 12 | 0 / 9 |
| serious Total, serious adverse events | 0 / 12 | 0 / 9 |
Outcome results
Primary
Acceptability of Peer Navigation
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care/Text Messaging | Acceptability of Peer Navigation | Very Unlikely to Recommend | 0 Participants |
| Standard of Care/Text Messaging | Acceptability of Peer Navigation | Unlikely to Recommend | 0 Participants |
| Standard of Care/Text Messaging | Acceptability of Peer Navigation | Neither Unlikely nor Likely to Recommend | 0 Participants |
| Standard of Care/Text Messaging | Acceptability of Peer Navigation | Likely to Recommend | 1 Participants |
| Standard of Care/Text Messaging | Acceptability of Peer Navigation | Very Likely to Recommend | 3 Participants |
| Standard of Care/Text Messaging | Acceptability of Peer Navigation | Data Missing (e.g. Survey not completed or question left blank) | 5 Participants |
Primary
Acceptability of Text Messaging
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care/Text Messaging | Acceptability of Text Messaging | Very Unlikely to Recommend | 0 Participants |
| Standard of Care/Text Messaging | Acceptability of Text Messaging | Unlikely to Recommend | 0 Participants |
| Standard of Care/Text Messaging | Acceptability of Text Messaging | Neither Unlikely nor Likely to Recommend | 1 Participants |
| Standard of Care/Text Messaging | Acceptability of Text Messaging | Likely to Recommend | 0 Participants |
| Standard of Care/Text Messaging | Acceptability of Text Messaging | Very Likely to Recommend | 1 Participants |
| Standard of Care/Text Messaging | Acceptability of Text Messaging | Data Missing (e.g. Survey not completed, question left blank) | 1 Participants |
| Peer Navigation | Acceptability of Text Messaging | Very Likely to Recommend | 1 Participants |
| Peer Navigation | Acceptability of Text Messaging | Very Unlikely to Recommend | 0 Participants |
| Peer Navigation | Acceptability of Text Messaging | Likely to Recommend | 0 Participants |
| Peer Navigation | Acceptability of Text Messaging | Unlikely to Recommend | 1 Participants |
| Peer Navigation | Acceptability of Text Messaging | Data Missing (e.g. Survey not completed, question left blank) | 1 Participants |
| Peer Navigation | Acceptability of Text Messaging | Neither Unlikely nor Likely to Recommend | 0 Participants |
Secondary
PrEP Adherence
PrEP 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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care/Text Messaging | PrEP Adherence | No DBS collected | 8 Participants |
| Standard of Care/Text Messaging | PrEP Adherence | <2 doses/week | 1 Participants |
| Standard of Care/Text Messaging | PrEP Adherence | 7 doses/week | 2 Participants |
| Standard of Care/Text Messaging | PrEP Adherence | 2-3 doses/week | 1 Participants |
| Standard of Care/Text Messaging | PrEP Adherence | BLQ | 0 Participants |
| Standard of Care/Text Messaging | PrEP Adherence | 4-6 doses/week | 0 Participants |
| Peer Navigation | PrEP Adherence | BLQ | 1 Participants |
| Peer Navigation | PrEP Adherence | No DBS collected | 3 Participants |
| Peer Navigation | PrEP Adherence | 4-6 doses/week | 2 Participants |
| Peer Navigation | PrEP Adherence | 7 doses/week | 1 Participants |
| Peer Navigation | PrEP Adherence | <2 doses/week | 1 Participants |
| Peer Navigation | PrEP Adherence | 2-3 doses/week | 1 Participants |
Secondary
PrEP Persistence
Persistence 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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care/Text Messaging | PrEP Persistence | 4 Participants |
| Peer Navigation | PrEP Persistence | 6 Participants |