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Oral HIV Self-Implemented Testing: Performance Fidelity Among African American MSM

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Abstract

Oral-Self Implemented HIV Testing (Oral-SIT) offers a low-cost way to extend the reach of HIV testing systems. It is unclear, however, if high risk populations are able to perform the test with high fidelity. Using a simulation-based research design, we administered desensitized Oral-SIT kits to African American MSM (AAMSM; 17–24 years, N = 178). Participants were HIV negative or never tested, and had never self-administered an Oral-SIT kit. We assessed performance fidelity, and hypothesized antecedents. High levels of social stigma were associated with lower levels of training knowledge (Range = No Errors: 51.9%, 4 Errors: 0.6%) and performance fidelity (Range = No Errors: 39.9%, 3 Errors: 1.7%). Training knowledge and prior testing history were positively associated with performance fidelity. The present work extends research on HIV-related social stigma and suggests that social stigma inhibits knowledge acquisition and task performance. The Oral-SIT training materials were understood by individuals with a wide-range of educational backgrounds. Interventions are needed, however, to further improve Oral-SIT performance fidelity.

Resumen

La Prueba Oral de VIH Auto-Implementada (Oral-PAI) ofrece una forma de bajo costo para extender el alcance de los sistemas de prueba de VIH. Sin embargo, no está claro si las poblaciones de alto riesgo pueden realizarse esta prueba con alta fidelidad. Usando un diseño de investigación basado en simulación, administramos kits desensibilizados de Oral-PAI a HSH Afro-Americanos (HSHAA; 17–24 años, N = 178). Los participantes eran VIH-negativo o nunca se habían hecho la prueba, y nunca se habían auto-administrado un kit de Oral-PAI. Evaluamos la fidelidad al desempeño de la tarea y los antecedentes hipotetizados. Los altos niveles de estigma social se asociaron con niveles más bajos de conocimiento de la capacitación (Rango = Sin errores: 51.9%, 4 Errores: 0.6%) y fidelidad en el desempeño de la actividad (Rango = Sin errores: 39.9%, 3 Errores: 1.7%). El conocimiento de la capacitación y el historial de pruebas previas se asociaron positivamente con la fidelidad al desempeño. El presente trabajo amplía la investigación sobre el estigma social relacionado con el VIH y sugiere que el estigma social inhibe la adquisición de conocimiento y el desempeño de tareas. Los materiales de capacitación de la Oral-PAI fueron entendidos por personas con una amplia gama de antecedentes educativos. Sin embargo, se necesitan intervenciones para mejorar aún más la fidelidad del desempeño de la Oral-PAI.

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Acknowledgements

This study was funded by Grants MH105180 and HD085780 to Dr. Catania. Special thanks to Donald Tyler, Alan Johnson, Jaclyn Shea, Kenneth Pass, and Tori Geter for their efforts in data collection and management. Special thanks for preparation of this manuscript to Logan Weeks and Aimee Miller. Much appreciation OraSure Corporation for their preparation of de-sensitized Oral-SITs.

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Correspondence to Joseph A. Catania.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. All procedures, consent materials, and interview protocols were approved by the University of Michigan IRB which served as the primary IRB for this project (IRB approval was ceded by Oregon State University to the University of Michigan IRB).

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Informed consent was obtained from all individual participants included in the study.

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Appendices

Appendix 1

Eligibility Criteria: (a) self-identifying as African American/black, (b) self-reporting being born as a male or currently identifying as a male, (c) being 17–24 years of age inclusive, (d) having sex of any kind with another male in the past 12 months, (e) being HIV negative or of unknown HIV status, and (f) having never self-administered an Oral-SIT test.

Procedures: Interviewers: Interviewers (2 African American men, 1 South Asian man, and 1 White female) were certified HIV testing counselors with experience working in the Chicago AAMSM community. Training sessions included observation and feedback with staff role-playing participants and actual participants in pilot simulations. Interviewers were trained to 100% reliability in making behavioral observations.

Procedures: Recruitment: Participants were recruited through posters and flyers at the research sites and were provided a $40 incentive for completing the study. Participants were told during recruitment, the consent process, and in the simulation instructions that they would be self-administering a desensitized test that would not provide HIV test results. Prospective participants were probed during the consent process as to their understanding that this was not an actual test. The study protocol called for excluding participants who were visibly distraught, intoxicated, or under the influence of drugs. No participants were excluded for these reasons.

Pre-simulation participant instructions: Participants were instructed as follows, [Interviewer]: As I mentioned earlier, the oral HIV self-test is a pain free test that people can use at home. Today, I am asking for your help with evaluating the instructions and procedures for the oral HIV test. The test you are using today will not tell you if you have HIV… The instructions for this test are in three different pieces. There is some information on the box, a video, and this plastic box that has a flip chart with instructions, some pamphlets, and the materials you need to test yourself [Interviewer: Show materials as you mention them.]. I will give you some instructions as we go along, but for the most part I want you to follow the instructions described in the kit’s flip chart and the instructional video

The simulation procedures:

  1. 1.

    The participant was instructed on how to use the flip chart and laptop showing the video. Participants were required to watch both the video and use the flip-chart to ensure that each participant was exposed to all training components (video, flip-chart, pamphlets). Participants engaged these training components to whatever extent they liked. Interviewers provided no additional information or aid in understanding any of the instructional materials, instructing participants to save any test relevant questions until they completed the simulation and final interview.

  2. 2.

    While the participants were using the Oral-SIT kit, interviewers made behavioral observations and notes on how engaged participants were in the instruction materials and noted any challenges participants were having (see Appendix 2).

  3. 3.

    The training materials instructed participants to open the test tube and place it on a specially designed holder. The interviewer observed if participants (a) opened the tube and transferred it appropriately without spilling a significant amount of the reagent, (b) removed the oral swab from the packaging and were careful not to touch the specimen swab with their fingers or to place it on the counter top, (c) obtained an oral specimen by first swabbing the upper gum and then, after reversing the swab, from the lower gums, (d) placed the swab into the tube containing the reagent such that the specimen portion of the stick was fully submerged in the testing solution, and (e) correctly wrote down their start time, the minimum 20 min interval time, and the maximum 40 min interval time.

  4. 4.

    We assessed the ability to read the test results by presenting participants with flashcards (post-simulation interview) depicting the different types of HIV test results as they would appear on an Oral-SIT specimen swab.

Post-simulation debriefing: To correct any false impressions, at study’s end, participants were debriefed to clarify misperceptions or inaccuracies in their Oral-SIT performance. Participants were provided a referral list to HIV test sites and treatment centers. If participants wished to receive more intensive counseling, they were referred to an on-call clinician.

Appendix 2

Behavioral Observation Checklist: The total fidelity measure is composed of the following:

  • R correctly opened the test tube and placed in the kit holder.

  • R did not spill the contents of the tube between opening and transferring to the holder.

  • R swabbed his gums correctly (without contaminating the test swab).

  • R placed the specimen stick correctly into the test tube.

  • R wrote times down correctly to achieve an accurate result (Start, 20, & 40 min).

  • R correctly evaluated the negative test result card.

  • R correctly evaluated the positive test result card.

  • R correctly evaluated the indeterminant test result card.

Knowledge of Oral-SIT Procedures: (a) What is the shortest period of time you need to wait between putting the test stick in the tube and taking it out to read the result?, (b) Is it ok to take the stick out of the tube and put it back in again before you read the result?, (c) What’s the most time you can leave the test stick in the tube and still get an accurate answer (reading)?, (d) What did the video/reading materials tell you about using food, gum, or drinking anything before using the test?, (e) What did the video/reading materials tell you about how to use the test stick? [If R did not address, ask:] Did the instructions say it was ‘ok’ to swipe your gums more than once?.

Adapted Social Stigma Items: The original Fortenberry scales were developed in young adult populations (United States; male & female, multiple races & sexual orientation groups) at high risk for STIs/HIV and adult samples in Kenya [5, 43]. In the U.S. higher levels of social stigma were associated with lower HIV and STI test seeking. The adapted scales factor analyzed into two factors. Only the self-image scale was significantly related to current study outcomes. This scale reflects social stigma related self-image outcomes including both negative and positive items regarding how the respondent perceives men who get HIV (see Table 4). This measure was administered in the post-simulation interview. Our factor analyses indicated that one item out of seven items in the self-image scale was found to have a trivial loading (0.054) and was deleted. The remaining 6 items all had factor loadings > 0.34.

Table 4 Social stigma self-image scale (4-point agree-disagree scales)

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Catania, J.A., Dolcini, M.M., Harper, G. et al. Oral HIV Self-Implemented Testing: Performance Fidelity Among African American MSM. AIDS Behav 24, 395–403 (2020). https://doi.org/10.1007/s10461-019-02711-5

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