A Web-Based Intervention to Reduce Decision Conflict Regarding HIV Pre-Exposure Prophylaxis: Protocol for a Clinical Trial
Bibliographic record
Abstract
BACKGROUND: HIV pre-exposure prophylaxis (PrEP) is recommended for populations at high ongoing risk for infection. There are noted racial disparities in the incidence of HIV and other sexually transmitted infections (STIs) for African, Caribbean, and Canadian Black (ACB, black) populations in Ontario, Canada. Although blacks represent only 4.7% of the Ontario population, they account for 30% of HIV prevalence and 25% of new infections in the province. The existing clinical public health practice toolkit has not been sufficient to optimize PrEP uptake, despite the overwhelming evidence of PrEP's efficacy for reducing HIV transmission risk. Since its establishment as an effective HIV prevention tool, the major focus in behavioral research on PrEP has been on understanding and improving adherence. To date, there is no known formalized intervention in place designed to support ACB men and women at high risk of making high-quality decisions regarding the adoption of PrEP as an HIV prevention practice. OBJECTIVE: We propose 2 aims to address these gaps in HIV prevention and implementation science. First, the Ottawa Decision Support Framework (ODSF) for use in the PrEP decisional needs of black patients was adapted. Second, the decision support intervention to estimate effect size compared with control conditions in reducing decision conflict and predicting adherence over 60 days was pilot tested. METHODS: In aim 1, we propose a cross-sectional qualitative descriptive study using data collected from key informant interviews with eligible PrEP patients (n=30) and surveys with health professionals (n=20) involved in HIV PrEP management. Data obtained from aim 1 will be used to develop a decision support intervention based on the ODSF. In aim 2, the adopted decision support intervention using a block-randomized design to estimate effect size compared with control conditions in reducing decision conflict and predicting adherence over 60 days was pilot tested. Hypothesis testing will be de-emphasized in favor of generating effect size estimates. RESULTS: A research award was funded on March 25, 2017 (Multimedia Appendix 1). Ethical approval was received on March 25, 2019 (with supplemental approval received on May 10, 2019). Data collection started on April 9, 2019. As of September 30, 2019, we enrolled 29 patients and 24 health care providers for aim 1. We are currently analysing the data collected for aim 1. Aim 2 is scheduled to start in May 2020. CONCLUSIONS: This study will provide evidence-based information on the decisional needs of black patients who are at risk of HIV and have been offered PrEP. The study will also test the effect of decision support intervention in reducing decision conflict, adoption of PrEP, and adherence to PrEP. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/15080.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.028 | 0.034 |
| Meta-epidemiology (narrow) | 0.005 | 0.003 |
| Meta-epidemiology (broad) | 0.008 | 0.005 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.005 | 0.004 |
| Scholarly communication | 0.005 | 0.004 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.008 | 0.010 |
| Insufficient payload (model declined to judge) | 0.120 | 0.020 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".