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September 2001, Vol 91, No. 9 | American Journal of Public Health 1377-1379
© 2001 American Public Health Association

FIELD ACTION REPORT

Retaining Hard-to-Reach Women in HIV Prevention and Vaccine Trials: Project ACHIEVE

Pamela Brown-Peterside, PhD, Evelyn Rivera, Debbie Lucy, MS, Izzie Slaughter, MPH, Leigh Ren, MS, Mary Ann Chiasson, DrPH and Beryl A. Koblin, PhD

Pamela Brown-Peterside, Evelyn Rivera, Debbie Lucy, Izzie Slaughter, Leigh Ren, and Beryl A. Koblin are with the Laboratory of Epidemiology, New York Blood Center, New York, N.Y. Mary Ann Chiasson was with the New York City Department of Health.

Correspondence: Requests for reprints should be sent to Pamela Brown-Peterside, PhD, Laboratory of Epidemiology, New York Blood Center, 1309 Fulton Avenue, Room 312, Bronx, NY 10456 (e-mail: pbrownpeterside{at}nybc.org).


   ABSTRACT
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Project ACHIEVE, which conducts HIV prevention research studies, maintains a women's site in the South Bronx in New York City. Owing to a focused retention effort at the South Bronx site, high retention rates were achieved in a vaccine preparedness study for women at high risk of HIV infection. Comparable retention rates have been achieved in HIV vaccine trials with similar cohorts of women at this site. These results suggest that concerns about retaining hard-to-reach populations should not cause these populations to be excluded from HIV vaccine and prevention trials.


   INTRODUCTION
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DISCUSSION AND EVALUATION
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FINDING A PREVENTIVE vaccine for HIV will mean asking people at high risk for HIV infection to participate in vaccine efficacy trials.1 Although vaccine preparedness studies indicate that high-risk cohorts are willing to participate in trials,2,3 many women at risk for HIV infection in the United States are poor and disenfranchised4 and are confronted with life issues that can interfere with their ability to adhere to scheduled study visits.5,6 To ensure broad participation in clinical trials and other cohort studies by those at high risk for HIV infection, we must develop successful retention strategies.7

From April to September 1998, Project ACHIEVE's South Bronx site (maintained by collaboration between the New York Blood Center and the New York City Department of Health) enrolled 164 HIV-negative women, aged 18 to 60 years, in a vaccine preparedness study as part of a larger multisite study. To qualify as being at high risk of HIV infection, each participant had to meet 1 or more of the following criteria: have a current male sex partner who was HIV infected or an injection drug user, or in the past year have smoked crack, exchanged sex for money or drugs, had 5 or more male sex partners, or had a sexually transmitted disease. Women who reported injection drug use in the past 3 years were excluded. Recruitment strategies included street outreach, newspaper ads, flyers, posters, and tabling in clinics and at health fairs. At enrollment, most of the women were poor; half of them reported 5 or more partners or exchanging sex for money or drugs, and two thirds had smoked crack in the preceding year (Table 1Go).


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  		TABLE 1—— Demographics and HIV Risk Profile of Women in Project ACHIEVE (n = 164): New York City, 1998
 
At the initial visit, informed consent and locator information were obtained, eligibility was confirmed, vaccine trial information was provided, willingness to participate in vaccine trials was assessed, and sexual and drug history interviews were conducted with Audio Computer-Assisted Self-Interviewing technology. Women were counseled and tested for HIV. Participants returned 2 weeks later. Those who tested positive were referred to primary care. Those who tested negative were enrolled in the study and returned to the clinic for further counseling and testing every 6 months for 1 year. Referrals for social services were provided when needed. At the 3-month and 9-month time points, participants were contacted to verify their locator information, be offered additional HIV testing, and confirm their next appointment.


   DISCUSSION AND EVALUATION
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Three months after enrollment, we were able to contact 98% of the participants (Figure 1Go). Six months into the study, 96% of enrollees completed study visits. At the 9-month contact point, we reached 96% of the participants. At the 12-month visit, 92% of enrollees completed their study visits; 88% completed both the 6-month and the 12-month visits. Baseline characteristics such as being younger than 36 years, spending at least 1 night at no fixed address in the previous 6 months, not having Medicaid, having attempted suicide, and not being recruited through a friend all predicted a lower likelihood of completing both study visits. A multiple logistic regression model predicting failure to complete both the 6-month and the 12-month visits found that participants who had attempted suicide were 3 times more likely than others not to complete both visits (odds ratio = 3.38; 95% confidence interval 1.14–10.08). None of the other baseline covariates were significant factors for loss to follow-up (data not shown).



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  		FIGURE 1—— Retention rates at each contact or visit (n = 164): Project ACHIEVE, New York City, 1998.

 
To enhance our chances of retaining this population, we made retention a priority from the start. During recruitment, we explicitly stated that enrollees would be required to provide the names and addresses of 2 contact people who did not live with the participant. We also collected contact information regarding each participant's physician and case manager. For all names provided, participants signed a consent that allowed us to inquire with their contacts about their whereabouts if necessary.

At each visit, women were reimbursed for their time ($20), given a $3 Metrocard to cover round-trip public transportation, and offered male and female condoms and small gifts. Appointment scheduling was flexible. Sometimes we saw participants before or after hours or on weekends. For participants who entered residential drug treatment programs, we conducted visits on site whenever possible.

The counseling that women received was part of our approach. It offered them support to cope with the difficulties in their lives and may have helped them keep their appointments. This support took the form of a listening ear; a shoulder to cry on; care packages of toiletries for those without homes; and referrals to social services agencies for assistance with housing, drug treatment, domestic violence, mental health, welfare, and employment.

When participants missed appointments, we made phone calls and sent letters. Home visits were also made by the outreach worker at different times of the day—sometimes 3 or 4 times—until contact was reestablished or it was clear that a participant had moved. If we could not locate participants, we checked to see if they had been incarcerated or become homeless. Because we were unable to continue doing study visits with incarcerated participants, we knew not to keep looking for them. For those in the homeless shelter system, we retrieved an updated address and reestablished contact.

Retention support for this population requires at least 1 full-time staff member who focuses on retention; financial support for home visits, such as car service (about $25 round-trip); and a computerized tracking system.


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The efforts reported here are purely descriptive; in the absence of a comparison group, we have no way of knowing which specific strategies contributed to retention. Furthermore, this work is based on a vaccine preparedness study, not on participation in an actual vaccine trial.

Vaccine preparedness studies mimic clinical trials in terms of visit schedules, educational content, and HIV counseling, but they contain no investigational agent. It is essential to know whether retention rates such as ours can be replicated with women in vaccine trials. We are involved in 2 multisite HIV vaccine trials with cohorts of high-risk women similar to those described here. Our local retention rates for these studies are 100% for a small 2-year phase II trial (n = 6) and 95% after 12 months for a phase III trial (n = 56).

Our findings suggest that high-risk women who are living in poverty can be successfully retained in HIV vaccine trials. Preconceived ideas about retention are no reason to exclude hard-to-reach populations from HIV vaccine or other prevention trials.


Highlights

  • Project ACHIEVE in New York's South Bronx successfully retained, in a cohort study, women at high risk of HIV infection.
  • Ninety-two percent of women enrolled in the vaccine preparedness study remained in the study after 1 year.
  • Retention rates like this have been replicated in HIV vaccine trials with similar cohorts of women at this site.
  • Concerns about retaining hard-to-reach populations should not cause the exclusion of high-risk women from participating in HIV vaccine and other prevention trials.

 


   Acknowledgments
 
The vaccine preparedness study was supported by the National Institute of Allergy and Infectious Diseases through a subcontract from Abt Associates (NO1-AI-35176) to the New York Blood Center (B. Koblin, principal investigator) and was part of the HIV Network for Prevention Trials. The study was approved by the Institutional Review Boards of the New York Blood Center and the New York City Department of Health. All participants provided written informed consent before enrolling in the study. Parts of this report were presented at the Society for Women's Health Research meeting on Women and Clinical Research in New Orleans in May 2000.


   Footnotes
 
Peer Reviewed

The content of this report does not necessarily reflect the views or policies of the US Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US government.

P. Brown-Peterside conceptualized the report, directed analysis and interpretation, and wrote the manuscript. E. Rivera, D. Lucy, and I. Slaughter conducted the retention efforts and reviewed and edited drafts of the manuscript. L. Ren conducted the data analysis and computed the retention rates. M. A. Chiasson and B. A. Koblin participated in conception and design and reviewed and edited drafts of the manuscript.

Accepted for publication January 5, 2001.


   References
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 ABSTRACT
 INTRODUCTION
 DISCUSSION AND EVALUATION
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 References
 
1. Bloom BR. A Perspective on AIDS Vaccines. Science. 1996;272:1888– 1890.[Free Full Text]

2. Koblin BA, Heagerty P, Sheon A, et al. Readiness of high-risk populations in the HIV Network for Prevention Trials to participate in HIV vaccine efficacy trials in the United States. AIDS.1998;12:785–793.[Medline]

3. Seage GE III, Metzger D, Holte S, Buchbinder S, Koblin B, Celum C. Feasibility of conducting HIV-1 vaccine trials in the United States: recruitment, retention and HIV-1 seroincidence from the HIV Network for Prevention Trials (HIVNET) Vaccine Preparedness Study (VPS). Am J Epidemiol.2001;153:619– 627.[Abstract/Free Full Text]

4. Zierler S, Kreiger N. Reframing women's risk: social inequalities and HIV infection. Annu Rev Public Health, 1997;18:401–436.[Medline]

5. Brown-Peterside P, Smith C, Affleck P, Doherty-Iddings P, Harrison C, Clark C. Enabling women to participate in HIV vaccine efficacy trials: lessons learned from a US vaccine preparedness study. Poster presented at: 12th World AIDS Conference; June 28–July 3, 1998; Geneva.

6. Brown-Peterside P, Chiasson MA, Ren L, Koblin BA. Involving women in HIV vaccine efficacy trials: lessons learned from a vaccine preparedness study in New York City. J Urban Health.2000;77:425–437[Medline]

7. Hunt JR, White E. Retaining and tracking cohort study members. Epidemiol Rev.1998;20:57–70.[Free Full Text]





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