Linking women experiencing incarceration to community-based HIV pre-exposure prophylaxis care: protocol of a pilot trial

Susan E Ramsey, Evan G Ames, Lauren Brinkley-Rubinstein, Anne M Teitelman, Jennifer Clarke, Clair Kaplan, Susan E Ramsey, Evan G Ames, Lauren Brinkley-Rubinstein, Anne M Teitelman, Jennifer Clarke, Clair Kaplan

Abstract

Background: Women experiencing incarceration (WEI) engage in high rates of sex- and drug-related behavior that places them at risk for HIV. Pre-exposure prophylaxis (PrEP) is an efficacious means of reducing HIV acquisition. There is a general lack of knowledge regarding PrEP among women at elevated risk, and only a small percentage of at-risk women are currently engaged in PrEP care. The period of incarceration represents an opportunity to identify at-risk women, initiate PrEP during incarceration, and establish linkage to community-based PrEP care upon release from incarceration. Further, post-release is a time period that is particularly risky, and there are numerous barriers, including substance use, that may impede linkage to community-based care in the absence of intervention. The current protocol describes plans for the development and pilot randomized controlled trial (RCT) of an intervention to promote PrEP uptake during incarceration and facilitate linkage to community-based PrEP care post-release.

Methods/design: The motivational interviewing-navigation (MI-NAV) study intervention is being developed, refined, and tested over three phases within the framework of the social ecological model. All phases of the study are being conducted at a women's correctional facility and community-based PrEP provider located in the Northeastern region of the United States. Phase 1 consists of individual qualitative interviews to be conducted with key stakeholders (n = 6-10) from the community-based PrEP care site and (n = 6-10) from the women's correctional facility, as well as with (n = 18-30) WEI. Recruitment for Phase 1 was initiated in November 2017. In Phase 2, MI-NAV will be piloted with a small cohort (n = 8-12) of WEI and will be refined based upon participant feedback. During Phase 3, a pilot RCT of MI-NAV and a standard of care condition will be conducted with 80 WEI. RCT participants will complete baseline and follow-up assessments 1, 3, and 6 months post-release. The primary study outcome is linkage to community-based PrEP care, verified via medical records.

Discussion: This study will develop and evaluate a psychosocial intervention (MI-NAV) to promote PrEP uptake and facilitate linkage to community-based PrEP care among women at-risk for HIV. It is expected that, as a result of this project, the feasibility, acceptability, and preliminary efficacy of MI-NAV will be determined. If found to be efficacious, this intervention has the potential to reduce HIV acquisition in a high-need, underserved community. Clinical trial registration NCT03281343.

Keywords: HIV prevention; Linkage to care; Pre-exposure prophylaxis; Women experiencing incarceration.

Figures

Fig. 1
Fig. 1
Brief description of the components and flow of the study phases
Fig. 2
Fig. 2
Examples of questions from individual interviews in Phase 1
Fig. 3
Fig. 3
Example questions from individual interviews post-release in Phase 2

References

    1. De Groot AS, Cu Uvin S. HIV infection among women in prison: considerations for care. Infect Dis Correct Rep. 2005;8(5&6):1–4.
    1. McClelland GM, Teplin LA, Abram KM, Jacobs N. HIV and AIDS risk behaviors among female jail detainees: implications for public health policy. Am J Public Health. 2002;92(5):818–825.
    1. Adams LM, Kendall S, Smith A, Quigley E, Stuewig JB, Tangney JP. HIV risk behaviors of male and femail jail inmates prior to incarceration and one year post-release. AIDS Behav. 2013;17(8):2685–2694.
    1. Binswanger IA, Mueller SR, Beaty BL, Min S, Corsi KF. Gender and risk behaviors for HIV and sexuallly transmitted infections among recently released inmates: a prospective cohort study. AIDS Care. 2014;26(7):872–881.
    1. Zhu GA, Birnbaum N, Caroll-Scott A, Evans L, Fiellin LE, Wang EA. Gender differences in HIV risk behaviors in individuals recently released from prison: results of a pilot study. Health Justice. 2015;3:6.
    1. Adams J, Nowels C, Corsi K, Long J, Steiner JF, Binswanger IA. HIV risk after release from prison: a qualitative study of former inmates. J Acquir Immune Defic Syndr. 2011;57(5):429–434.
    1. Brinkley-Rubinstein L, Dauria E, Tolou-Shams M, Christopoulos K, Chan PA, Beckwith CG, et al. The path to implementation of HIV pre-exposure prophylaxis for people involved in criminal justice systems. Curr HIV/AIDS Rep. 2018;15(2):93–95.
    1. Rutledge R, Madden L, Ogbuagu O, Meyer JP. HIV risk perception and eligibility for pre-exposure prophylaxis in women involved in the criminal justice system. AIDS Care. 2018;11:1–8.
    1. Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, et al. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2013;381(9883):2083–2090.
    1. Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012;367(5):423–434.
    1. Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral prophylaxis for HIV-1 prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399–410.
    1. Wu H, Mendoza MCB, Huang YA, Hayes T, Smith DK, Hoover KW. Uptake of HIV preexposure prophylaxis among commercially insured persons—United Sates, 2010–2014. Clin Infect Dis. 2017;64(2):144–149.
    1. Health CIfISiP. Ending the AIDS epidemic dashboard: PrEP use in New York State; 2018.
    1. Sheth AN, Rolle CP, Gandhi M. HIV pre-exposure prophylaxis for women. J Virus Erad. 2016;2(3):149–155.
    1. Smith DK, Toledo L, Smith DJ, Adams M, Rothenberg R. Attitudes and program preferences of African-American urban young adults about pre-exposure prophylaxis (PrEP) AIDS Educ Prev. 2012;24(5):408–421.
    1. Auerbach JD, Kinsky S, Brown G, Charles V. Knowledge, attitudes, and likelihood of pre-exposure prophylaxis (PrEP) use among US women at risk of acquiring HIV. AIDS Patient Care STDs. 2015;29(2):102–110.
    1. Whiteside YO, Harris T, Scanlon C, Clarkson S, Duffus W. Self-perceived risk of HIV infection and attitudes about preexposure prophlaxis among sexually transmitted disease clinic attendees in South Carolina. AIDS Patient Care STDs. 2011;25(6):365–370.
    1. Miller WR, Rollnick S. Motivational intervieiwing: preparing people for change. New York: Guilford Press; 2002.
    1. Miller WR, Rollnick S. Motivational interviewing: helping people change. New York: Guilford; 2013.
    1. Belcher L, Kalichman S, Topping M, Smith S, Emshoff J, Norris F, et al. A randomized trial of a brief HIV risk reduction counseling intervention for women. J Consult Clin Psychol. 1998;65:531–541.
    1. Carey MP, Maisto SA, Kalichman SC, Forsyth AD, Wright EM, Johnson BT. Enhancing motivation to reduce the risk of HIV infection for economically disadvantaged urban women. J Consult Clin Psychol. 1997;65(4):531–541.
    1. Weir BW, O’Brien K, Bard RS, Casciato CJ, Maher JE, Dent CW, et al. Reducing HIV and partner violence risk among women with criminal justice system involement: a randomized controlled trial of two Motivational Interviewing-based interventions. AIDS Behav. 2009;13(3):509–522.
    1. Underhill K, Dumont D, Operario D. HIV prevention for adults with criminal jutice involvement: a systematic review of HIV risk-reduction interventions in incarceration and community settings. Am J Public Health. 2014;104(11):e27–e53.
    1. Azar MM, Springer SA, Meyer JP, Altice FL. A systematic review of the impact of alcohol use disorders on HIV treatment outcomes, adherence to antiretroviral therapy and health care utilization. Drug Alcohol Depend. 2011;112(3):178–193.
    1. Gonzalez A, Mimiaga MJ, Isreal J, Andres Bedoya C, Safren SA. Substance use predictors of poor medication adherence: the role of substance use coping among HIV-infected patients in opioid dependence. AIDS Behav. 2013;17(1):168–173.
    1. Chitsaz E, Meyer JP, Krishnan A, Springer SA, Marcus R, Zaller N, et al. Contribution of substance use disorders on HIV treatment outcomes and antiretroviral medication adherence among HIV-infected persons entering jail. AIDS Behav. 2013;17(Suppl 2):S119–S127.
    1. Gonzalez JS, Batchelder AW, Psaros C, Safren SA. Depression and HIV/AIDS treatment nonadherence: a review and meta-analysis. J Acquir Immune Defic Syndr. 2013;58(2):181–187.
    1. van Olphen J, Eliason MJ, Freudenberg N, Barnes M. Nowhere to go: how stigma limits the options of female drug users after release from jail. Subst Abuse Treat Prev Policy. 2009;4:10.
    1. Lincoln T, Kennedy S, Tuthill R, Roberts C, Conklin TJ, Hammett TM. Facilitators and barriers to continuing healthcare after jail: a community-integrated program. J Ambul Care Manag. 2006;29(1):2–16.
    1. Wang EA, White MC, Jamison R, Goldenson J, Estes M, Tulsky JP. Discharge planning and continuity of health care: findings from the San Fransicso County Jail. Am J Public Health. 2016;98(12):2182–2184.
    1. Paskett ED, Harrop JP, Wells KJ. Patient navigation: an update on the state of the science. CA Cancer J Clin. 2011;61(4):237–249.
    1. Bradford JB, Coleman S, Cunningham W. HIV system navigation: an emerging model to improve HIV care access. AIDS Patient Care STDs. 2007;21:S49–S58.
    1. Scott CK, Dennis ML. The first 90 days following release from jail: findings from the recovery management checkups for women offenders (RMCWO) experiment. Drug Alcohol Depend. 2012;125(1–2):110–118.
    1. Bronfrenbrenner U. The ecology of human development: Experiments by nature and design. Cambridge: Harvard University; 1979.
    1. Philbin MM, Parker CM, Parker RG, Wilson PA, Garcia J, Hirsch JS. The promise of pre-exposure prophylaxis for black men who have sex with men: an ecological approach to attitudes, beliefs, and barriers. AIDS Patient Care STDs. 2016;30(6):282–290.
    1. Onken LS, Carroll KM, Shoham V, Cuthbert BN, Riddle M. Reenvisioning clinical science: unifying the discipline to improve the public health. Clin Psychol Sci. 2014;2(1):22–34.
    1. Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, et al. Framework for design and evaluation of complex interventions to improve health. BMJ Br Med J. 2000;321(7262):694–696.
    1. Centers for Disease Control and Prevention . Preexposure prophylaxis for the prevention of HIV infection in the United States, 2014: a clinical practice guideline. Atlanta: Centers for Disease Control and Prevention; 2014.
    1. Shih F. Triangulation in nursing research: issues of conceptual clarity and purpose. J Adv Nurs. 1998;28(3):631–641.
    1. Guest G, MacQueen KM, Namey E. Applied thematic analysis. Thousand Oaks: Sage Publications; 2012.
    1. Gale NK, Gemma H, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;2013(13):117.
    1. Navaline HA, Snider EC, Petro CJ, Tobin D, Metzger D, Alterman AI, et al. Preparations for AIDS vaccine trials. An automated version of the Risk Assessment Battery (RAB): enhancing the assessment of risk behaviors. AIDS Res Hum Retrovir. 1994;10(Suppl 2):S281–S283.
    1. Castillo-Mancilla JR, Zheng J, Rower JE, Medtiz A, Gardner EM, Predhomme J, et al. Tenofovir, emtricitabine, and tenofovir diphosphate in dried blood spots for determining recent and cumulative drug exposure. AIDS Res Hum Retrovir. 2013;29(2):384–390.
    1. Wilson IB, Lee Y, Michaud J, Fowler FJ, Jr, Rogers WH. Validation of a new three-item self-report measure for medication adherence. AIDS Behav. 2016;20(11):2700–2708.
    1. Van der Elst EM, Mbogua J, Operario D, Mutua G, Kuo C, Mugo P, et al. High acceptability of HIV pre-exposure prophylaxis but challenges in adherence and use: qualitative insights from a Phase I Trial of intermittent and daily PrEP in at-risk populations in Kenya. AIDS Behav. 2013;17(6):2162–2172.
    1. Mugo PM, Sanders EJ, Mutua G, Van der Elst E, Anzala O, Barin B, et al. Understanding adherence to daily and intermittent regimens of oral HIV pre-exposure prophylaxis among men who have sex with men in Kenya. AIDS Behav. 2015;19(5):794–801.
    1. Hunter CE, Palepu A, Farrell S, Gogosis E, O’Brien K, Hwang SW. Barriers to prescription medication adherence among homelessness and vulnerably house adults in three Canadian cities. J Prim Care Community Health. 2015;6(3):154.
    1. Leaver CA, Bargh G, Dunn JR, Hwang SW. The effects of housing status on health-related outcomes in people living with HIV: a systematic review of the literature. AIDS Behav. 2007;11(Suppl 2):S85–S100.
    1. Sobell LC, Sobell MB. Validity of self-reports in three populations of alcoholics. J Consult Clin Psychol. 1979;46:901–907.
    1. Sobell LC, Sobell MB. Convergent validity: an approach to increasing confidence in treatment outcome conclusions with alcohol and drug abusers. In: Sobell LC, Sobell MB, Ward E, editors. Evaluating alcohol and drug abuse treatment effectiveness: recent advances. New York: Pergamon Press; 1980.
    1. Sobell MB, Maisto SA, Sobell LC, Cooper AM, Cooper T, Sanders B. Developing a prototype for evaluating alcohol treatment effectiveness. In: Sobell LC, Sobell MB, Ward E, editors. Evaluating alcohol and drug abuse treatment effectiveness: Recent advances. New York: Pergamon; 1980. pp. 129–150.
    1. Lewinsohn PM, Seeley JR, Roberts RE, Allen NB. Center for Epidemiological Studies-Depression(CES-D) as a screening instrument for depression among community-residing older adults. Psychol Aging. 1997;12:277–287.
    1. Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plan. 1979;2(3):197–207.
    1. Wester B, Braga A, Hureau D, Sirois C. Study retention as bias reduction in a hard-to-reach population. Proc Natl Acad Sci USA. 2016;113(20):5477–5485.
    1. Wester B, Braga A, Kohl R. A longitudinal survey of newly-released prisoners: methods and design of the Boston Reentry Study. Fed Probat. 2017;81(1):32–40.
    1. Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006;63:484–489.
    1. Papke LE, Wooldridge JM. Panel data methods for fractional response variables with an application to test pass rates. J Econ. 2008;145(1–2):121–133.
    1. Hall SM, Delucchi KL, Velicer WF, Kahler CW, Ranger-Moore J, Hedeker D, et al. Statistical analysis of randomized trials in tobacco treatment: longitudinal designs with dichotomous outcome. Nicotine Tobacco. 2001;3:193–202.
    1. Liang KY, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73(1):13–22.
    1. Zeger SL, Liang KY. Longitudinal data analysis for discrete and continuous outcomes. Biometrics. 1986;42(121):130.
    1. Little RJ, Rubin DB. Statistical analysis with missing data. New York: Wiley; 1987.
    1. Noska AJ, Roberts MB, Sufrin C, Stein LAR, Beckwith CG, Rich JD, et al. History of sex exchange in women with a history of incarceration. J Health Care Poor Underserved. 2016;27(2A):149–162.
    1. Knudsen HK, Leukefeld C, Havens JR, Duvall JL, Oser CB, Staton-Tindall M, et al. Partner relationships and HIV risk behaviors among women offenders. J Psychoact Drugs. 2008;40(4):471–481.
    1. Greenfield SF, Brooks AJ, Gordon SM, Green CA, Kropp F, McHugh RK, et al. Substance abuse treatment entry, retention, and outcome in women: a review of the literature. Drug Alcohol Depend. 2007;86(1):1–21.

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