Skip to main content
SpringerLink
Log in

Perceptions and Experiences with the VOICE Adherence Strengthening Program (VASP) in the MTN-003 Trial

  • Original Paper
  • Published:
AIDS and Behavior Aims and scope Submit manuscript

Abstract

The VOICE Adherence Strengthening Program (VASP) was implemented in May 2011 to improve adherence counseling in VOICE (MTN-003), a multisite placebo-controlled trial of daily oral or vaginal tenofovir-based Pre-Exposure Prophylaxis (PrEP). Anonymous baseline (N = 82) and final follow-up (N = 75) surveys were administered to counselors and pharmacists at 15 VOICE sites, and baseline (N = 18) and final (N = 26) qualitative in-depth interviews were conducted with purposively selected counseling staff at 13 VOICE sites. Qualitative interviews with VOICE participants (N = 38) were also analyzed for segments related to counseling. Behavioral and biological measures of product use collected in the 6 months prior to VASP implementation were compared to those collected during the 6 months following implementation. Results show that the majority of staff preferred VASP and thought that participants preferred VASP over the previous education and counseling strategy, although there was no evidence to suggest that participants noticed modifications in the counseling approach. No meaningful changes were observed in pre/post levels of reported use or drug detection. Interpretation of results is complicated by mid-trial implementation of VASP and its proximity to early closure of oral and vaginal tenofovir study arms because of futility.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

Notes

  1. Please note that the term “counseling staff” globally refers to a range of site staff (e.g., counselors, nurse/counselor and/or pharmacists) who provide product adherence counseling to participants. “Counselor” refers to the specific cadre of staff that are counselors or nurse/counselors.

  2. Of note, behavioral adherence assessment was already separate from counseling; it was collected through ACASI and interviewer-based questionnaires..

References

  1. Baeten JM, Grant R. Use of antiretrovirals for HIV prevention: what do we know and what don’t we know? Curr HIV/AIDS Rep. 2013;10:142–51.

    Article  PubMed Central  PubMed  Google Scholar 

  2. van der Straten A, Van Damme L, Haberer JE, Bangsberg DR. Unraveling the divergent results of pre-exposure prophylaxis trials for HIV prevention. AIDS (London, England). 2012;26(7):F13–9.

    Article  Google Scholar 

  3. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363(27):2587–99.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  4. Karim QA, Karim SSA, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329:1168–74.

    Article  Google Scholar 

  5. Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. NEJM. 2012;367:399–410.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  6. Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. NEJM. 2012;367(5):423–34.

    Article  CAS  PubMed  Google Scholar 

  7. 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):2083–90.

    Article  PubMed  Google Scholar 

  8. Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, et al. Preexposure prophylaxis for HIV infection among African women. NEJM. 2012;367:411–22.

    Article  PubMed Central  PubMed  Google Scholar 

  9. Marrazzo J, Ramjee G, Nair G, Palanee T, Mkhize B, Nakabiito C, et al. Pre-exposure prophylaxis for HIV in women: daily oral tenofovir, oral tenofoviremtricitabine, or vaginal tenofovir gel in the VOICE Study (MTN 003). CROI. March 3–6, 2013; Atlanta GA2013.

  10. Hendrix CW. Exploring concentration response in HIV pre-exposure prophylaxis to optimize clinical care and trial design. Cell. 2013;155(3):515–8.

    Article  CAS  PubMed  Google Scholar 

  11. Amico KR, Stirratt MJ. Adherence to preexposure prophylaxis: current, emerging, and anticipated bases of evidence. Clin Infect Dis. 2014;59(Suppl 1):s55–s60.

  12. Amico KR, Mansoor L, Corneli A, Torjesen K, van der Straten A. Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials. AIDS Behav. 2013;17:2143–55.

    Article  PubMed Central  PubMed  Google Scholar 

  13. Koenig LJ, Lyles C, Smith DK. Adherence to antiretroviral medications for HIV pre-exposure prophylaxis: lessons learned from trials and treatment studies. Am J Prev Med. 2013;44(1 Suppl 2):S91–8.

    Article  PubMed  Google Scholar 

  14. Marrazzo J, Ramjee G, Nair G, Palanee T, Mkhize B, Nakabiito C, et al. Pre-exposure prophylaxis for HIV in women: Daily oral tenofovir, oral tenofoviremtricitabine, or vaginal tenofovir gel in the voice study (mtn 003). NEJM. 2014 forthcoming.

  15. Amico K, McMahan V, Goicochea P, Vargas L, Marcus JL, Grant RM, et al. Supporting study product use and accuracy in self-report in the IPREX study: next step counseling and neutral assessment. AIDS Behav. 2012;16(5):1243–59.

    Article  Google Scholar 

  16. Microbicide trials network statement on decision to discontinue use of oral tenofovir tablets in voice, a major HIV prevention study in women. Microbicide Trials Network; 2011.

  17. Microbicide trials network statement on decision to discontinue use of tenofovir gel in voice, a major HIV prevention study in women. 2011.

  18. van der Straten A, Stadler J, Montgomery E, Hartmann M, Magazi B, Mathebula F, et al. Women’s experiences with oral and vaginal pre-exposure prophylaxis: the voice-c qualitative study in Johannesburg, South Africa. PLoS One. 2014;9(2):e89118.

    Article  PubMed Central  PubMed  Google Scholar 

  19. Hendrix CW, Andrade A, Kashuba A, Marzinke M, Anderson PL, Moore A, et al. Tenofovir-emtricitabine directly observed dosing: 100 % adherence concentrations (hptn 066). 21st Conference on Retorviruses and Opportunistic Infections; March 3–6; Boston, 2014.

  20. Schwartz JL, Rountree W, Kashuba ADM, Brache V, Creinin MD, Poindexter A, et al. A multi-compartment, single and multiple dose pharmacokinetic study of the vaginal candidate microbicide 1 % tenofovir gel. PLoS One. 2011;6(10):e25974.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  21. Mansoor LE, Karim QA, Werner L, Madlala B, Ngcobo N, Cornman DH, et al. Impact of an adherence intervention on the effectiveness of tenofovir gel in the Caprisa 004 trial. AIDS Behav. 2014;18(5):841–8.

    Article  PubMed  Google Scholar 

  22. Mansoor LE, Abdool Karim Q, Yende-Zuma N, MacQueen KM, Baxter C, Madlala BT, et al. Adherence in the Caprisa 004 tenofovir gel microbicide trial. AIDS Behav. 2014;81:811–9.

    Article  Google Scholar 

  23. Dewing S, Mathews C, Schaay N, Cloete A, Louw J, Simbayi L. Behaviour change counseling for arv adherence support within primary health care facilities in the Western Cape, South Africa. AIDS Behav. 2012;16:1286–94.

    Article  CAS  PubMed  Google Scholar 

  24. Schwartz K, Ndase P, Torjesen K, Mayo A, Scheckter R, van der Straten A, et al. Supporting participant adherence through structured engagement activities in the MTN-020 (aspire) trial. Community Engagement in Prevention Research, HIV Research for Prevention 2014 (HIV R4P); Cape Town, South Africa, October 28–31, 2014.

  25. Corneli A, Perry B, Agot K, Ahmed K, McKenna K, Malamatsho F, et al. Fem-prep: participant explanations for non-adherence. Conference on Retroviruses and Opportunistic Infections; Boston, Mass. 2014.

  26. van der Straten A, Montgomery E, Hartmann M, Levy L, Piper J, Mensch B. Strategies to explore factors impacting study product adherence among women in VOICE. IAPAC Conference; June 8–10, 2014; Miami, Florida. 2014.

Download references

Acknowledgments

The authors gratefully acknowledge the MTN-003 and MTN003C study participants, research team, site staff, and site communities. Specifically we would like to thank Dr. Jonathan Stadler, Busisiwe Magazi, Florence Mathebula and the other VOICE-C researchers at the Wits Reproductive Health and HIV Institute in South Africa. We would like to thank Catie Magee, Dr. Elizabeth Montgomery, Miriam Hartmann, and Andrea Hanson of WGHI/RTI International, in helping with different aspects of ACME data collection and/or study report writing. The contributions of the MTN Behavioral Research Working Group, the VOICE trial leadership, Kaila Gomez of FHI 360, and other study team members are acknowledged as critical in the development and implementation of this study. The full MTN-003 study team can be viewed at http://www.mtnstopshiv.org/people/emailgroups/86/cards. MTN-003 was funded by the US National Institutes of Health (NIH). The Microbicide Trials Network is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Author information

Authors and Affiliations

  1. Women’s Global Health Imperative (WGHI), RTI International, 351 California Street, Suite 500, San Francisco, CA, 94104, USA

    Ariane van der Straten, Helen Cheng & Nicole Laborde

  2. Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, USA

    Ariane van der Straten

  3. FHI 360, Durham, NC, USA

    Ashley Mayo & Kristine Torjesen

  4. Fred Hutchinson Cancer Research Center, Seattle, WA, USA

    Elizabeth R. Brown

  5. Center for Health, Intervention and Prevention, University of Connecticut, Storrs, CT, USA

    K. Rivet Amico

  6. University of Washington, Seattle, USA

    Elizabeth R. Brown & Jeanne Marrazzo

Authors
  1. Ariane van der Straten
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Ashley Mayo
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Elizabeth R. Brown
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. K. Rivet Amico
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Helen Cheng
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Nicole Laborde
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Jeanne Marrazzo
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Kristine Torjesen
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Ariane van der Straten.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

van der Straten, A., Mayo, A., Brown, E.R. et al. Perceptions and Experiences with the VOICE Adherence Strengthening Program (VASP) in the MTN-003 Trial. AIDS Behav 19, 770–783 (2015). https://doi.org/10.1007/s10461-014-0945-2

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10461-014-0945-2

Keywords

Search

Navigation