ART Readiness in HIV-infected Pregnant Women

NCT02459678 | Completed

• 1 other identifier: 13-3884
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to evaluate the readiness of HIV-infected pregnant women in Zambia to initiate, adhere to, and be retained in care under the Ministry of Health's Option B+ policy. Under a 3-phased research study the investigators will: (1) conduct formative research regarding readiness to start lifelong ART in the pregnant population; (2) translate the results of formative research into a readiness assessment tool and an enhanced adherence package for pregnant women eligible for Option B+ and (3) conduct an individual randomized trial of the enhanced adherence package.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (2)

• Proportion of women who both initiate ART and are retained in care

  ART eligibility in the setting of Option B+ will generally be either the date of HIV diagnosis for pregnant women newly diagnosed with HIV infection during their antenatal care visit or the date of their first antenatal care visit for known HIV-infected pregnant women who are not already on ART

  Within 30 days of eligibility to begin ART under Option B+ policy

• HIV virologic suppression at time of delivery

  Outcome of virologic suppression at delivery will be analyzed for differences between the SOC arm and intervention arm.

  Time of delivery

Secondary Outcomes (2)

• Time from ART eligibility to ART initiation

  Time from ART eligibility to initiation from enrollment until 6 months post-partum

• HIV transmission from mother to infant

  At 6 weeks and 6 months of life

Study Arms (2)

Standard of Care

OTHER

The MOH-recommended approach is opt out HIV testing in pregnancy followed by immediate initiation of ART for HIV-infected pregnant women. ART initiation is accompanied with counseling geared to educate and prepare women to take up and be retained on ART lifelong. Women who do not return for clinical or drug refill visits are traced by phone or in person.

Other: Standard of Care

Enhanced adherence package

EXPERIMENTAL

The enhanced adherence package will be designed on the basis of the results of formative research. The intervention will support women who are eligible for ART under Option B+.

Behavioral: Enhanced Adherence Package

Interventions

Enhanced Adherence Package BEHAVIORAL

The enhanced adherence package is yet to be designed, but may target all HIV-infected women with methods that are currently reserved only for late clients or clients of unknown status.

Enhanced adherence package

Standard of Care OTHER

Currently, the standard of care is based on the 2010 national HIV care and treatment guidelines, health care providers are encouraged to use a number of different means to improve ART adherence.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected pregnant women not yet on ART OR
• HIV-infected pregnant or postnatal women on ART OR
• Partners of women who were recently or are currently pregnant

You may not qualify if:

• Less than 18 years old
• Known history of mental illness
• Phase 2
• HIV-infected pregnant or postnatal women on ART who piloted tested the readiness assessment tool OR
• Health care workers involved in provision of PMTCT and/or ART services at health facility who have pilot tested the readiness assessment tool
• Phase 3
• Pregnant
• HIV-infected
• Never previously initiated or was on ART for her own health
• Able to provide informed consent
• Willing to undergo all study tests and procedures and be followed until 6 months post-partum
• Less than 18 years old
• Known intrauterine fetal demise
• Known history of mental illness
• Does not intend to receive antenatal care, labour and delivery care, and postnatal care at the government health facilities of Lusaka District

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Centre for Infectious Disease Research in Zambia: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Centre for Infectious Disease Research in Zambia

Lusaka, Zambia

Location

Related Publications (66)

• Millennium Development Goals Progress Report. 2011, Ministry of Finance and National Planning, UNDP: Lusaka.

  BACKGROUND

• National HIV/AIDS/STIs/TB Council, 2009 HIV Epidemiological Projections Report. 2009: Zambia.

  BACKGROUND

• Republic of Zambia Ministry of Health, National Protocol Guidelines Integrated Prevention of Mother-to-Child Transmission of HIV, Directorate of Public Health and Research, Editor. 2010, Ministry of Health: Lusaka, Zambia.

  BACKGROUND

• Government of the Republic of Zambia, National Protocol Guidelines Integrated Prevention of Mother-to-Child Transmission of HIV/AIDS, M.o. Health, Editor. 2008: Lusaka.

  BACKGROUND

• Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants: Recommendations for a Public Health Approach: 2010 Version. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK304944/

  PMID: 26180894 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Impact of an innovative approach to prevent mother-to-child transmission of HIV--Malawi, July 2011-September 2012. MMWR Morb Mortal Wkly Rep. 2013 Mar 1;62(8):148-51.

  PMID: 23446514 BACKGROUND

• Government of the Republic of Zambia, Lifelong Antiretroviral Drugs (ARV's) for all HIV positive Pregnant Women in Zambia, M.o. Health, Editor. 2013: Lusaka.

  BACKGROUND

• Government of the Republic of Zambia, Adult and Adolescent Antiretroviral Therapy Protocols, M.o. Health, Editor. 2010: Lusaka.

  BACKGROUND

• Shaffer N, Abrams EJ, Becquet R. Option B+ for prevention of mother-to-child transmission of HIV in resource-constrained settings: great promise but some early caution. AIDS. 2014 Feb 20;28(4):599-601. doi: 10.1097/QAD.0000000000000144. No abstract available.

  PMID: 24469000 BACKGROUND

• Tenthani L, Haas AD, Tweya H, Jahn A, van Oosterhout JJ, Chimbwandira F, Chirwa Z, Ng'ambi W, Bakali A, Phiri S, Myer L, Valeri F, Zwahlen M, Wandeler G, Keiser O. Retention in care under universal antiretroviral therapy for HIV-infected pregnant and breastfeeding women ('Option B+') in Malawi. AIDS. 2014 Feb 20;28(4):589-598. doi: 10.1097/QAD.0000000000000143.

  PMID: 24468999 BACKGROUND

• UNAIDS. HIV and AIDS estimates 2009. [cited 2011 April 11]; Available from: http://www.unaids.org/en/regionscountries/countries/zambia/.

  BACKGROUND

• Zambia National HIV/AIDS/STI/TB Council, Zambia HIV Prevention Response and Modes of Transmission Analysis. 2009.

  BACKGROUND

• Mazimba C, C.W., , Kaseba C, Chi B, HIV-related maternal mortality in Lusaka, Zambia: 1993-2004, in 3rd IAS Conference on HIV Pathogenesis and Treatment: Rio de Janeiro, Brazil.

  BACKGROUND

• Moodley J, Pattinson RC, Baxter C, Sibeko S, Abdool Karim Q. Strengthening HIV services for pregnant women: an opportunity to reduce maternal mortality rates in Southern Africa/sub-Saharan Africa. BJOG. 2011 Jan;118(2):219-25. doi: 10.1111/j.1471-0528.2010.02726.x. Epub 2010 Sep 24.

  PMID: 21159120 BACKGROUND

• McIntyre J. Maternal health and HIV. Reprod Health Matters. 2005 May;13(25):129-35. doi: 10.1016/s0968-8080(05)25184-4.

  PMID: 16035606 BACKGROUND

• Kuhn L, Aldrovandi GM, Sinkala M, Kankasa C, Semrau K, Kasonde P, Mwiya M, Tsai WY, Thea DM; Zambia Exclusive Breastfeeding Study (ZEBS). Differential effects of early weaning for HIV-free survival of children born to HIV-infected mothers by severity of maternal disease. PLoS One. 2009 Jun 26;4(6):e6059. doi: 10.1371/journal.pone.0006059.

  PMID: 19557167 BACKGROUND

• Kuhn L, Aldrovandi GM, Sinkala M, Kankasa C, Mwiya M, Thea DM. Potential impact of new WHO criteria for antiretroviral treatment for prevention of mother-to- child HIV transmission. AIDS. 2010 Jun 1;24(9):1374-7.

  PMID: 20568677 BACKGROUND

• Sewankambo NK, Gray RH, Ahmad S, Serwadda D, Wabwire-Mangen F, Nalugoda F, Kiwanuka N, Lutalo T, Kigozi G, Li C, Meehan MP, Brahmbatt H, Wawer MJ. Mortality associated with HIV infection in rural Rakai District, Uganda. AIDS. 2000 Oct 20;14(15):2391-400. doi: 10.1097/00002030-200010200-00021.

  PMID: 11089628 BACKGROUND

• Bicego G, Boerma JT, Ronsmans C. The effect of AIDS on maternal mortality in Malawi and Zimbabwe. AIDS. 2002 May 3;16(7):1078-81. doi: 10.1097/00002030-200205030-00019. No abstract available.

  PMID: 11953479 BACKGROUND

• Morgenstern TT, Grimes DE, Grimes RM. Assessment of readiness to initiate antiretroviral therapy. HIV Clin Trials. 2002 Mar-Apr;3(2):168-72. doi: 10.1310/T6Y6-BRCW-AR7A-WVA3.

  PMID: 11976996 BACKGROUND

• Nachega JB, Uthman OA, Anderson J, Peltzer K, Wampold S, Cotton MF, Mills EJ, Ho YS, Stringer JS, McIntyre JA, Mofenson LM. 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 Oct 23;26(16):2039-52. doi: 10.1097/QAD.0b013e328359590f.

  PMID: 22951634 BACKGROUND

• Weigel R, Hosseinipour MC, Feldacker C, Gareta D, Tweya H, Chiwoko J, Gumulira J, Kalulu M, Mofolo I, Kamanga E, Mwale G, Kadzakumanja A, Jere E, Phiri S. Ensuring HIV-infected pregnant women start antiretroviral treatment: an operational cohort study from Lilongwe, Malawi. Trop Med Int Health. 2012 Jun;17(6):751-9. doi: 10.1111/j.1365-3156.2012.02980.x. Epub 2012 Apr 5.

  PMID: 22487553 BACKGROUND

• Wagner GJ, Goggin K, Remien RH, Rosen MI, Simoni J, Bangsberg DR, Liu H; MACH14 Investigators. A closer look at depression and its relationship to HIV antiretroviral adherence. Ann Behav Med. 2011 Dec;42(3):352-60. doi: 10.1007/s12160-011-9295-8.

  PMID: 21818528 BACKGROUND

• Balfour L, Kowal J, Silverman A, Tasca GA, Angel JB, Macpherson PA, Garber G, Cooper CL, Cameron DW. A randomized controlled psycho-education intervention trial: Improving psychological readiness for successful HIV medication adherence and reducing depression before initiating HAART. AIDS Care. 2006 Oct;18(7):830-8. doi: 10.1080/09540120500466820.

  PMID: 16971295 BACKGROUND

• Tremblay CL, Baril JG, Fletcher D, Kilby D, Macpherson P, Shafran SD, Tyndall MW. Challenges in initiating antiretroviral therapy in 2010. Can J Infect Dis Med Microbiol. 2010 Aug;21 Suppl C(Suppl C):1C-15C.

  PMID: 23365594 BACKGROUND

• Fehr JS, Nicca D, Sendi P, Wolf E, Wagels T, Kiss A, Bregenzer T, Vernazza P, Jager H, Spirig R, Battegay M; Swiss HIV Cohort Study. Starting or changing therapy - a prospective study exploring antiretroviral decision-making. Infection. 2005 Aug;33(4):249-56. doi: 10.1007/s15010-005-4141-1.

  PMID: 16091895 BACKGROUND

• Wolff B, Mbonye M, Coutinho A, Amuron B, Nkabala R, Jaffar S, Grosskurth H. High levels of psychosocial readiness for ART in an African population at the onset of treatment. SAHARA J. 2009 Dec;6(4):188-94. doi: 10.1080/17290376.2009.9724947.

  PMID: 20485858 BACKGROUND

• Macdonell KE, Naar-King S, Murphy DA, Parsons JT, Harper GW. Predictors of medication adherence in high risk youth of color living with HIV. J Pediatr Psychol. 2010 Jul;35(6):593-601. doi: 10.1093/jpepsy/jsp080. Epub 2009 Sep 15.

  PMID: 19755495 BACKGROUND

• Tessema B, Biadglegne F, Mulu A, Getachew A, Emmrich F, Sack U. Magnitude and determinants of nonadherence and nonreadiness to highly active antiretroviral therapy among people living with HIV/AIDS in Northwest Ethiopia: a cross-sectional study. AIDS Res Ther. 2010 Jan 14;7:2. doi: 10.1186/1742-6405-7-2.

  PMID: 20180959 BACKGROUND

• Central Statistical Office, Demographic Health Survey. 2007: Lusaka.

  BACKGROUND

• Weiss L, French T, Finkelstein R, Waters M, Mukherjee R, Agins B. HIV-related knowledge and adherence to HAART. AIDS Care. 2003 Oct;15(5):673-9. doi: 10.1080/09540120310001595159.

  PMID: 12959818 BACKGROUND

• Johnson MO, Gamarel KE, Dawson Rose C. Changing HIV treatment expectancies: a pilot study. AIDS Care. 2006 Aug;18(6):550-3. doi: 10.1080/09540120500241439.

  PMID: 16831781 BACKGROUND

• Pence BW, Ostermann J, Kumar V, Whetten K, Thielman N, Mugavero MJ. The influence of psychosocial characteristics and race/ethnicity on the use, duration, and success of antiretroviral therapy. J Acquir Immune Defic Syndr. 2008 Feb 1;47(2):194-201. doi: 10.1097/QAI.0b013e31815ace7e.

  PMID: 17971712 BACKGROUND

• Johnson MO, Dilworth SE, Stephens E, Lum PJ, Neilands TB. Expectancy and readiness-based predictors of treatment uptake among the urban poor living with HIV. J Acquir Immune Defic Syndr. 2011 Dec 15;58(5):469-71. doi: 10.1097/QAI.0b013e3182365671.

  PMID: 21926630 BACKGROUND

• Grimes RM, Grimes DE. Patient readiness to adhere to HAART. J Int Assoc Physicians AIDS Care (Chic). 2009 Nov-Dec;8(6):364-6. doi: 10.1177/1545109709351240.

  PMID: 19952288 BACKGROUND

• Wagner G, Iguchi M, Schneider S, Scott J, Anderson D. Placebo practice trials: a tool to assess and improve adherence readiness. HIV Clin Trials. 2002 Nov-Dec;3(6):475-81. doi: 10.1310/WQRY-FNUL-VNE1-56XA.

  PMID: 12501131 BACKGROUND

• Wagner GJ, Kanouse DE, Koegel P, Sullivan G. Correlates of HIV antiretroviral adherence in persons with serious mental illness. AIDS Care. 2004 May;16(4):501-6. doi: 10.1080/09540120410001683420.

  PMID: 15203417 BACKGROUND

• Willey C, Redding C, Stafford J, Garfield F, Geletko S, Flanigan T, Melbourne K, Mitty J, Caro JJ. Stages of change for adherence with medication regimens for chronic disease: development and validation of a measure. Clin Ther. 2000 Jul;22(7):858-71. doi: 10.1016/s0149-2918(00)80058-2.

  PMID: 10945512 BACKGROUND

• Konkle-Parker DJ. A motivational intervention to improve adherence to treatment of chronic disease. J Am Acad Nurse Pract. 2001 Feb;13(2):61-8. doi: 10.1111/j.1745-7599.2001.tb00219.x.

  PMID: 11930399 BACKGROUND

• Thompson MA, Mugavero MJ, Amico KR, Cargill VA, Chang LW, Gross R, Orrell C, Altice FL, Bangsberg DR, Bartlett JG, Beckwith CG, Dowshen N, Gordon CM, Horn T, Kumar P, Scott JD, Stirratt MJ, Remien RH, Simoni JM, Nachega JB. Guidelines for improving entry into and retention in care and antiretroviral adherence for persons with HIV: evidence-based recommendations from an International Association of Physicians in AIDS Care panel. Ann Intern Med. 2012 Jun 5;156(11):817-33, W-284, W-285, W-286, W-287, W-288, W-289, W-290, W-291, W-292, W-293, W-294. doi: 10.7326/0003-4819-156-11-201206050-00419. Epub 2012 Mar 5.

  PMID: 22393036 BACKGROUND

• Balfour L, Tasca GA, Kowal J, Corace K, Cooper CL, Angel JB, Garber G, Macpherson PA, Cameron DW. Development and validation of the HIV Medication Readiness Scale. Assessment. 2007 Dec;14(4):408-16. doi: 10.1177/1073191107304295.

  PMID: 17986658 BACKGROUND

• Grimes RM, Grimes DE. Readiness: the state of the science (or the lack thereof). Curr HIV/AIDS Rep. 2010 Nov;7(4):245-52. doi: 10.1007/s11904-010-0056-2.

  PMID: 20714831 BACKGROUND

• Fernandez MI, Hosek S, Warren JC, Jacobs RJ, Hernandez N, Martinez J; Adolescent Medicine Trials Network (ATN). Development of an easy to use tool to assess HIV treatment readiness in adolescent clinical care settings. AIDS Care. 2011 Nov;23(11):1492-9. doi: 10.1080/09540121.2011.565020. Epub 2011 Jun 21.

  PMID: 22022853 BACKGROUND

• Chi BH, Bolton-Moore C, Holmes CB. Prevention of mother-to-child HIV transmission within the continuum of maternal, newborn, and child health services. Curr Opin HIV AIDS. 2013 Sep;8(5):498-503. doi: 10.1097/COH.0b013e3283637f7a.

  PMID: 23872611 BACKGROUND

• Stubbs BA, Micek MA, Pfeiffer JT, Montoya P, Gloyd S. Treatment partners and adherence to HAART in Central Mozambique. AIDS Care. 2009 Nov;21(11):1412-9. doi: 10.1080/09540120902814395.

  PMID: 20024718 BACKGROUND

• Cook PF, McCabe MM, Emiliozzi S, Pointer L. Telephone nurse counseling improves HIV medication adherence: an effectiveness study. J Assoc Nurses AIDS Care. 2009 Jul-Aug;20(4):316-25. doi: 10.1016/j.jana.2009.02.008.

  PMID: 19576548 BACKGROUND

• Rodrigues R, Shet A, Antony J, Sidney K, Arumugam K, Krishnamurthy S, D'Souza G, DeCosta A. Supporting adherence to antiretroviral therapy with mobile phone reminders: results from a cohort in South India. PLoS One. 2012;7(8):e40723. doi: 10.1371/journal.pone.0040723. Epub 2012 Aug 27.

  PMID: 22952574 BACKGROUND

• Seidenberg P, Nicholson S, Schaefer M, Semrau K, Bweupe M, Masese N, Bonawitz R, Chitembo L, Goggin C, Thea DM. Early infant diagnosis of HIV infection in Zambia through mobile phone texting of blood test results. Bull World Health Organ. 2012 May 1;90(5):348-56. doi: 10.2471/BLT.11.100032.

  PMID: 22589568 BACKGROUND

• Webster PD, Sibanyoni M, Malekutu D, Mate KS, Venter WD, Barker PM, Moleko W. Using quality improvement to accelerate highly active antiretroviral treatment coverage in South Africa. BMJ Qual Saf. 2012 Apr;21(4):315-24. doi: 10.1136/bmjqs-2011-000381.

  PMID: 22438327 BACKGROUND

• Assefa Y, Kiflie A, Tekle B, Mariam DH, Laga M, Van Damme W. Effectiveness and acceptability of delivery of antiretroviral treatment in health centres by health officers and nurses in Ethiopia. J Health Serv Res Policy. 2012 Jan;17(1):24-9. doi: 10.1258/jhsrp.2011.010135. Epub 2011 Nov 17.

  PMID: 22096081 BACKGROUND

• Perez F, Aung KD, Ndoro T, Engelsmann B, Dabis F. Participation of traditional birth attendants in prevention of mother-to-child transmission of HIV services in two rural districts in Zimbabwe: a feasibility study. BMC Public Health. 2008 Dec 5;8:401. doi: 10.1186/1471-2458-8-401.

  PMID: 19061506 BACKGROUND

• Borghi J, Ensor T, Somanathan A, Lissner C, Mills A; Lancet Maternal Survival Series steering group. Mobilising financial resources for maternal health. Lancet. 2006 Oct 21;368(9545):1457-65. doi: 10.1016/S0140-6736(06)69383-5.

  PMID: 17055948 BACKGROUND

• Schmidt JO, Ensor T, Hossain A, Khan S. Vouchers as demand side financing instruments for health care: a review of the Bangladesh maternal voucher scheme. Health Policy. 2010 Jul;96(2):98-107. doi: 10.1016/j.healthpol.2010.01.008.

  PMID: 20138385 BACKGROUND

• Ekirapa-Kiracho E, Waiswa P, Rahman MH, Makumbi F, Kiwanuka N, Okui O, Rutebemberwa E, Bua J, Mutebi A, Nalwadda G, Serwadda D, Pariyo GW, Peters DH. Increasing access to institutional deliveries using demand and supply side incentives: early results from a quasi-experimental study. BMC Int Health Hum Rights. 2011 Mar 9;11 Suppl 1(Suppl 1):S11. doi: 10.1186/1472-698X-11-S1-S11.

  PMID: 21410998 BACKGROUND

• Kalembo FW, Zgambo M, Mulaga AN, Yukai D, Ahmed NI. Association between male partner involvement and the uptake of prevention of mother-to-child transmission of HIV (PMTCT) interventions in Mwanza district, Malawi: a retrospective cohort study. PLoS One. 2013 Jun 12;8(6):e66517. doi: 10.1371/journal.pone.0066517. Print 2013.

  PMID: 23776683 BACKGROUND

• Myer L, Zulliger R, Bekker LG, Abrams E. Systemic delays in the initiation of antiretroviral therapy during pregnancy do not improve outcomes of HIV-positive mothers: a cohort study. BMC Pregnancy Childbirth. 2012 Sep 11;12:94. doi: 10.1186/1471-2393-12-94.

  PMID: 22963318 BACKGROUND

• Krueger, R. and M. Casey, Focus Groups: A Practical Guide for Applied Research, 3rd edition. 2000, Thousand Oaks: Sage Publications.

  BACKGROUND

• Nordqvist O, Sodergard B, Tully MP, Sonnerborg A, Lindblad AK. Assessing and achieving readiness to initiate HIV medication. Patient Educ Couns. 2006 Jul;62(1):21-30. doi: 10.1016/j.pec.2005.09.014.

  PMID: 16766244 BACKGROUND

• Bernard, H.R., Research Methods in Anthropology. 1995, Walnut Creek Altamira Press 535.

  BACKGROUND

• Miles, M. and A. Huberman, Qualitative Data Analysis: An Expanded Sourcebook. 2nd ed. 1994, Thousand Oaks: Sage Publications.

  BACKGROUND

• Enriquez M, Lackey NR, O'Connor MC, McKinsey DS. Successful adherence after multiple HIV treatment failures. J Adv Nurs. 2004 Feb;45(4):438-46. doi: 10.1046/j.1365-2648.2003.02928.x.

  PMID: 14756838 BACKGROUND

• Gerbert B, Bronstone A, Clanon K, Abercrombie P, Bangsberg D. Combination antiretroviral therapy: health care providers confront emerging dilemmas. AIDS Care. 2000 Aug;12(4):409-21. doi: 10.1080/09540120050123819.

  PMID: 11091774 BACKGROUND

• Chibwesha CJ, Giganti MJ, Putta N, Chintu N, Mulindwa J, Dorton BJ, Chi BH, Stringer JS, Stringer EM. Optimal time on HAART for prevention of mother-to-child transmission of HIV. J Acquir Immune Defic Syndr. 2011 Oct 1;58(2):224-8. doi: 10.1097/QAI.0b013e318229147e.

  PMID: 21709566 BACKGROUND

• European Collaborative Study; Patel D, Cortina-Borja M, Thorne C, Newell ML. Time to undetectable viral load after highly active antiretroviral therapy initiation among HIV-infected pregnant women. Clin Infect Dis. 2007 Jun 15;44(12):1647-56. doi: 10.1086/518284. Epub 2007 May 2.

  PMID: 17516411 BACKGROUND

• Naar-King S, Parsons JT, Murphy D, Kolmodin K, Harris DR; ATN 004 Protocol Team. A multisite randomized trial of a motivational intervention targeting multiple risks in youth living with HIV: initial effects on motivation, self-efficacy, and depression. J Adolesc Health. 2010 May;46(5):422-8. doi: 10.1016/j.jadohealth.2009.11.198. Epub 2010 Feb 4.

  PMID: 20413077 BACKGROUND

• Mubiana-Mbewe M, Bosomprah S, Kadota JL, Koyuncu A, Kusanathan T, Mweebo K, Musokotwane K, Mulenga PL, Chi BH, Vinikoor MJ. Effect of Enhanced Adherence Package on Early ART Uptake Among HIV-Positive Pregnant Women in Zambia: An Individual Randomized Controlled Trial. AIDS Behav. 2021 Mar;25(3):992-1000. doi: 10.1007/s10461-020-03060-4. Epub 2020 Oct 8.

  PMID: 33033996 DERIVED

Related Links

• University of North Carolina website

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mwangelwa Mubiana, MBChB

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

• Benjamin Chi, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Michael J Vinikoor, MD

  Centre for Infectious Disease Research in Zambia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: June 2, 2015
• Study Start: May 1, 2015
• Primary Completion: May 9, 2018
• Study Completion: May 28, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

ZA (1)