How to promote PrEP adherence? A trial for participants of the Amsterdam PrEP project

A nested randomised controlled trial of the effect of adherence interventions: the AMPrEP App plus.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23409

Enrollment

150

Registered

2016-02-25

Start date

2016-03-07

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence to PrE-exposure prophylaxis

Interventions

Intervention: the AMPrEP App PLUS The intervention to improve adherence that will be tested in this RCT consists of individualized feedback provided in an AMPrEP App PLUS, based on the adherence date

Eligibility

Inclusion criteria

Inclusion criteria: All of the following: • Participant of the daily PrEP group within AMPrEP and prefers to continue daily PrEP use • Has installed and used the regular AMPrEP App on smart phone or tablet • Willing and able to comply to RCT procedures • Willing and able to give written informed consent

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
good adherence at 12 and 24 months. Good adherence is measured by tenofovir levels in dried blood spot. Good adherence is defined as a level of ≥700 fmol/punch, which corresponds to a use of four or more tablets per week of tenofovir/emtricitabine 29.	—

Secondary

Measure	Time frame
1. To assess the use of the AMPrEP App (control group) and the AMPrEP App PLUS (intervention group) 2. To compare acceptability and usability of the AMPrEP App (control group) and the AMPrEP App PLUS (intervention group) 3. To compare self-reported adherence from questionnaires, from the AMPrEP App (control group) and the AMPrEP App PLUS (intervention group) and from pill-counts in both groups 4. To evaluate risk compensation in both study groups 5. To determine the rate of HIV seroconversion in both groups 6. To determine the perceived level of HIV protection in both groups 7. To determine the level of adherence self-efficacy in both groups 8. To evaluate perceived adherence support of the AMPrEP App (control group) and the AMPrEP App PLUS (intervention group) 9. To assess whether demographic variables, drug use, sexual risk behaviour, STI prevalence, perceived HIV risk and beliefs on PrEP efficacy are independent predictors of adherence, as measured by tenofovir levels in dried blood spots	—

Measure

Time frame

1. To assess the use of the AMPrEP App (control group) and the AMPrEP App PLUS (intervention group) 2. To compare acceptability and usability of the AMPrEP App (control group) and the AMPrEP App PLUS (intervention group) 3. To compare self-reported adherence from questionnaires, from the AMPrEP App (control group) and the AMPrEP App PLUS (intervention group) and from pill-counts in both groups 4. To evaluate risk compensation in both study groups 5. To determine the rate of HIV seroconversion in both groups 6. To determine the perceived level of HIV protection in both groups 7. To determine the level of adherence self-efficacy in both groups 8. To evaluate perceived adherence support of the AMPrEP App (control group) and the AMPrEP App PLUS (intervention group) 9. To assess whether demographic variables, drug use, sexual risk behaviour, STI prevalence, perceived HIV risk and beliefs on PrEP efficacy are independent predictors of adherence, as measured by tenofovir levels in dried blood spots

—

Contacts

Public ContactMark van den Elshout

GGD Amsterdam

mvdelshout@ggd.amsterdam.nl0205559384

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)