Stepped-Wedge Cluster Randomized Controlled Trial to Promote Option B+ Retention in Central Mozambique

Journal of Acquired Immune Deficiency Syndromes

Volumn 76, Issue 3, 2017, Pages 273-280

  Pfeiffer, James T ^a,b   Napúa, Manuel ^c   Wagenaar, Bradley H ^a,b   Chale, Falume ^b   Hoek, Roxanne ^a   Micek, Mark ^d   Manuel, João ^c   Michel, Cathy ^b   Cowan, Jessica Greenberg ^b,e   Cowan, James F ^a,b   Gimbel, Sarah ^a,b   Sherr, Kenneth ^a,b   Gloyd, Stephen ^a,b   Chapman, Rachel R ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

^b HEALTH ALLIANCE INTERNATIONAL   (United States)

^c MINISTRY OF HEALTH   (Mozambique)

^d UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^e UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

Author keywords

ART adherence; implementation science; Mozambique; Option B+ retention; stepped wedge

Indexed keywords

ADULT; ANTIRETROVIRAL THERAPY; BIRTH; CHECKLIST; COHORT ANALYSIS; CONFERENCE PAPER; CONTROLLED STUDY; FEMALE; FOLLOW UP; HOME VISIT; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LIVE BIRTH; MAJOR CLINICAL STUDY; MEDICATION COMPLIANCE; MOZAMBIQUE; OPTION B; PATIENT COMPLIANCE; PATIENT COUNSELING; PREGNANT WOMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); STEPPED WEDGE CLUSTER; SUPPORT GROUP; TEXT MESSAGING; WORKFLOW; YOUNG ADULT; CD4 LYMPHOCYTE COUNT; HEALTH CARE DELIVERY; HIV INFECTIONS; MIDDLE AGED; ORGANIZATION AND MANAGEMENT; PATIENT ATTITUDE; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PREVENTION AND CONTROL; STATISTICS AND NUMERICAL DATA; VERTICAL TRANSMISSION;

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT;

ADULT; ANTI-HIV AGENTS; CD4 LYMPHOCYTE COUNT; DELIVERY OF HEALTH CARE; FEMALE; HIV INFECTIONS; HUMANS; INFECTIOUS DISEASE TRANSMISSION, VERTICAL; MEDICATION ADHERENCE; MIDDLE AGED; MOZAMBIQUE; PATIENT ACCEPTANCE OF HEALTH CARE; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; YOUNG ADULT;

EID: 85031708627     PISSN: 15254135     EISSN: 10779450     Source Type: Journal    
DOI: 10.1097/QAI.0000000000001515     Document Type: Conference Paper

References (56)

1. Barker PM, Mphatswe W, Rollins N. Antiretroviral drugs in the cupboard are not enough: the impact of health systems' performance on mother-to-child transmission of HIV. J Acquir Immune Defic Syndr. 2011;56:e45-e48.
2. Braun M, Kabue MM, McCollum ED, et al. Inadequate coordination of maternal and infant HIV services detrimentally affects early infant diagnosis outcomes in Lilongwe, Malawi. J Acquir Immune Defic Syndr. 2011;56:e122-e128.
3. Ferguson L, Grant AD, Lewis J, et al. Linking women who test HIVpositive in pregnancy-related services to HIV care and treatment services in Kenya: a mixed methods prospective cohort study. PLoS One. 2014;9: e89764.
4. Wettstein C, Mugglin C, Egger M, et al. Missed opportunities to prevent mother-to-child-transmission: systematic review and meta-analysis. AIDS. 2012;26:2361-2373.
5. Ferguson L, Lewis J, Grant AD, et al. Patient attrition between diagnosis with HIV in pregnancy-related services and long-term HIV care and treatment services in Kenya: a retrospective study. J Acquir Immune Defic Syndr. 2012;60:e90-e97.
6. Gamell A, Letang E, Jullu B, et al. Uptake of guidelines on prevention of mother-to-child transmission of HIV in rural Tanzania: time for change. Swiss Med Wkly. 2013;143:w13775.
7. Landes M, van Lettow M, Bedell R, et al. Mortality and health outcomes in HIV-infected and HIV-uninfected mothers at 18-20 months postpartum in Zomba District, Malawi. PLoS One. 2012;7:e44396.
8. van Lettow M, Bedell R, Landes M, et al. Uptake and outcomes of a prevention-of mother-to-child transmission (PMTCT) program in Zomba district, Malawi. BMC Public Health. 2011;11:426.
9. UNAIDS. UNAIDS Report on the Global AIDS Epidemic. Geneva, Switzerland: UNAIDS; 2013.
10. Nachega JB, Uthman OA, Anderson J, et al. Adherence to antiretroviral therapy during and after pregnancy in low-income, middle-income, and high-income countries: a systematic review and meta-analysis. AIDS. 2012;26:2039-2052.
11. WHO. Programmatic Update: WHO HIV/AIDS Programme Use of Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants. Geneva, Switzerland: World Health Organization; 2012.
12. WHO. Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: Recommendations for a Public Health Approach. Geneva, Switzerland: World Health Organization; 2013.
13. Ahmed S, Kim MH, Abrams EJ. Risks and benefits of lifelong antiretroviral treatment for pregnant and breastfeeding women: a review of the evidence for the Option B+ approach. Curr Opin HIV AIDS. 2013; 8:474-489.
14. Clouse K, Schwartz S, Van Rie A, et al. "What they wanted was to give birth; nothing else": barriers to retention in option B+ HIV care among postpartum women in South Africa. J Acquir Immune Defic Syndr. 2014; 67:e12-e18.
15. Clouse K, Pettifor A, Shearer K, et al. Loss to follow-up before and after delivery among women testing HIV positive during pregnancy in Johannesburg, South Africa. Trop Med Int Health. 2013;18:451-460.
16. Rollins NC, Becquet R, Orne-Gliemann J, et al. Defining and analyzing retention-in-care among pregnant and breastfeeding HIV-infected women: unpacking the data to interpret and improve PMTCT outcomes. J Acquir Immune Defic Syndr. 2014;67(suppl 2):S150-S156.
17. Shaffer N, Abrams EJ, Becquet R. Option B+ for prevention of motherto-child transmission of HIV in resource-constrained settings: great promise but some early caution. AIDS. 2014;28:599-601.
18. Helova A, Akama E, Bukusi EA, et al. Health facility challenges to the provision of Option B+ in western Kenya: a qualitative study. Health Policy Plann. 2017;32:283-291.
19. Mitiku I, Arefayne M, Mesfin Y, et al. Factors associated with loss to follow-up among women in Option B+ PMTCT programme in northeast Ethiopia: a retrospective cohort study. J Int AIDS Soc. 2016;19:20662.
20. Tenthani L, Haas AD, Tweya H, et al. Retention in care under universal antiretroviral therapy for HIV-infected pregnant and breastfeeding women ("Option B+") in Malawi. AIDS. 2014;28:589-598.
21. Centers for Disease C, Prevention. Impact of an innovative approach to prevent mother-to-child transmission of HIV-Malawi, July 2011-September 2012. MMWR Morb Mortal Wkly Rep. 2013;62:148-151.
22. (CDC) CfDCaP. Impact of an innovative approach to prevent mother-tochild transmission of HIV-Malawi, 2011-2012. MMWR Morb Mortal Wkly Rep. 2013;62:148-151.
23. Haas AD, Tenthani L, Msukwa MT, et al. Retention in care during the first 3 years of antiretroviral therapy for women in Malawi's option B+ programme: an observational cohort study. Lancet HIV. 2016;3:e175-e182.
24. Llenas-García J, Wikman-Jorgensen P, Hobbins M, et al. Retention in care of HIV-infected pregnant and lactating women starting art under Option B+ in rural Mozambique. Trop Med Int Health. 2016;21:1003-1012.
25. Asbjornsdottir KRA, Rustagi A, Coutinho J, et al. Low Retention in Option B+ Care Among Women in Mozambique. Women and HIV Intercfar Joint Symposium on HIV Research in Women. Birmingham, Alabama: Centers for AIDS Research; 2016.
26. Matheson R, Moses-Burton S, Hsieh AC, et al. Fundamental concerns of women living with HIV around the implementation of Option B. J Int AIDS Soc. 2015;18(6 suppl 5):20286.
27. Kieffer MP, Mattingly M, Giphart A, et al. Lessons learned from early implementation of option B+: the elizabeth glaser pediatric AIDS foundation experience in 11 African countries. J Acquir Immune Defic Syndr. 2014;67(suppl 4):S188-S194.
28. Gourlay A, Birdthistle I, Mburu G, et al. Barriers and facilitating factors to the uptake of antiretroviral drugs for prevention of mother-to-child transmission of HIV in sub-Saharan Africa: a systematic review. J Int AIDS Soc. 2013;16:18588.
29. CNCS. UNGASS: United Nations General Assembly Special Session on HIV and AIDS, Progress Report, 2008-2009 Mozambique. Maputo, Mozambique: National AIDS Council; 2010.
30. UNAIDS. Global Report: Report on the Global AIDS Epidemic 2013. Geneva, Switzerland: UNAIDS; 2013.
31. MISAU. Moçambique Inquérito Demográfico de Saúde 2011. Calverton, MD: ICF International/MEASURE DHS program; 2011.
32. MISAU. Relatorio Anual 2014: Relatorio Anual da Actividades Relacionadas ao HIV/SIDA. Maputo, Mozambique: Mozambique Ministry of Health.
33. Auld AF, Shiraishi RW, Couto A, et al. A decade of antiretroviral therapy scale-up in Mozambique: evaluation of outcome trends and new models of service delivery among more than 300,000 patients enrolled during 2004-2013. J Acquir Immune Defic Syndr. 2016;73:e11-e22.
34. Napua M, Pfeiffer JT, Chale F, et al. Option B+ in Mozambique: formative research findings for the design of a facility-level clustered randomized controlled trial to improve ART retention in antenatal care. J Acquir Immune Defic Syndr. 2016;72(suppl 2):S181-S188.
35. Mozambique Ministry of Health. 2009 National Survey on Prevalence, Behavioral Risks and Information about HIV and AIDS in Mozambique (INSIDA). Maputo, Mozambique: Mozambique Ministry of Health; 2009.
36. Mozambique Ministry of Health. PMTCT 2009 Programme Report. Maputo, Mozambique: Mozambique Ministry of Health; 2009.
37. Fernandes QF, Wagenaar BH, Anselmi L, et al. Effects of health-system strengthening on under-5, infant, and neonatal mortality: 11-year provincial-level time-series analyses in Mozambique. Lancet Glob Health. 2014;2:e468-e477.
38. Mozambique National Institute of Statistics, U.S. Census Bureau, MEASURE Evaluation, U.S. Centers for Disease Control and Prevention. Mortality in Mozambique: Results from a 2007-2008 Post-Census Mortality Survey. Chapel Hill, NC: MEASURE Evaluation; 2012.
39. MISAU. National Department of Medical Assistance, National Data Report 2010. Maputo, Mozambique: Antiretroviral Treatment; 2011.
40. CNCS. Resposta Global à SIDA; Relatório do Progresso, 2016, Mozambique. Maputo, Mozambique: National AIDS Council; 2016.
41. Pfeiffer J, Chapman R. Early ART Initiation Among HIV-Positive Pregnant Women in Central Mozambique Grant No. 1R01HD074557-01. Washington, DC: National Institute of Child Health and development; 2012.
42. Cowan JF, Micek M, Cowan JF, et al. Early ART initiation among HIVpositive pregnant women in central Mozambique: a stepped wedge randomized controlled trial of an optimized Option B+ approach. Implement Sci. 2015;10:61.
43. Pfeiffer J, Napua M. Chapman R, et al. Opton B+ in Mozambique: Challenges to Retention in Care. Poster Presented at 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention. Vancouver, CA: International AIDS Society; 2015.
44. Napúa MJ. Manuel L. Vieira G, et al. Factors contributing to loss to follow-up among HIV-exposed infants in Manica and Sofala provinces-Central Mozambique. 21st International AIDS Conference 2016. July 20, 2016; Durban, South Africa.
45. Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28:182-191.
46. Herlihy JM, Hamomba L, Bonawitz R, et al. Implementation and operational research: integration of PMTCT and antenatal services improves combination antiretroviral therapy uptake for HIV-positive pregnant women in southern Zambia: a prototype for option B+? J Acquir Immune Defic Syndr. 2015;70:e123-e129.
47. Dzangare J, Takarinda KC, Harries AD, et al. HIV testing uptake and retention in care of HIV-infected pregnant and breastfeeding women initiated on "Option B+"in rural Zimbabwe. Trop Med Int Health. 2016; 21:202-209.
48. Odeny TA, Bukusi EA, Cohen CR, et al. Texting improves testing: a randomized trial of two-way SMS to increase postpartum prevention of mother-to-child transmission retention and infant HIV testing. AIDS (London, England). 2014;28:2307-2312.
49. Ambia J, Mandala J. A systematic review of interventions to improve prevention of mother-to-child HIV transmission service delivery and promote retention. J Int AIDS Soc. 2016;19:20309.
50. Wagenaar BH, Gimbel S, Hoek R, et al. Wait and consult times for primary healthcare services in central Mozambique: a time-motion study. Glob Health Action. 2016;9:31980.
51. Fairley C, Permana A, Read T. Long-term utility of measuring adherence by self-report compared with pharmacy record in a routine clinic setting. HIV Med. 2005;6:366-369.
52. Altice FL, Mostashari F, Friedland GH. Trust and the acceptance of and adherence to antiretroviral therapy. J Acquir Immune Defic Syndr. 2001; 28:47-58.
53. Walsh JC, Horne R, Dalton M, et al. Reasons for non-adherence to antiretroviral therapy: patients' perspectives provide evidence of multiple causes. AIDS Care. 2001;13:709-720.
54. Harrigan PR, Hogg RS, Dong WW, et al. Predictors of HIV drugresistance mutations in a large antiretroviral-naive cohort initiating triple antiretroviral therapy. J Infect Dis. 2005;191:339-347.
55. Weiser SD, Guzman D, Riley ED, et al. Higher rates of viral suppression with nonnucleoside reverse transcriptase inhibitors compared to single protease inhibitors are not explained by better adherence. HIV Clin Trials. 2004;5:278-287.
56. Bangsberg DR, Moss AR, Deeks SG. Paradoxes of adherence and drug resistance to HIV antiretroviral therapy. J Antimicrob Chemother. 2004; 53:696-699.