Differentiated Care for Improved Health Systems Efficiency and Health Outcomes in Zambia

NCT02776254 | Completed

• 1 other identifier: ID OPP1105306
• Study Type: interventional
• Target: 3,100
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to create generalizable knowledge about the implementation process as well as the effectiveness and efficiency of a differentiated care system, by measuring patient health outcomes and implementation outcomes such as acceptability, feasibility, fidelity, and costs

Conditions

HIV

Keywords

anti-retroviral therapy; differentiated care

Outcome Measures

Primary Outcomes (1)

• Retention in care (Time to first missed pharmacy pick-up)

  Time to first missed pharmacy pick-up (\>7 days)

  12 months

Secondary Outcomes (15)

• Feasibility of implementing differentiated care from stakeholder perspectives

  12 months

• Feasibility of implementing differentiated care based on ART availability

  12 months

• Activity Based Costing (cost per activity based on Time and Motion)

  12 months

• Cost to patient based on semi-structured interviews

  12 months

• Research Costs (cost of conducting implementation science)

  12 months

Study Arms (6)

START

EXPERIMENTAL

The START model aims to deliver a higher intensity of treatment services by offering same-day CD4 testing and results, streamlined adherence counseling, and quicker initiation of life-long ART to patients enrolling in HIV care and treatment services.

Other: START

FAST Track

EXPERIMENTAL

In the FAST-TRACK model a pharmacy technician will dispense drugs) and lay health care workers will provide brief symptom screening to identify patients in need of higher-level care. If there is no need of higher-level care, then the clinic visit is over.

Other: FAST-TRACK

CAG (intervention)

EXPERIMENTAL

CAG intervention, consists of facilitated groups of six people based on geographic proximity of home address and patient preference. This group of six people, will meet monthly at a designated place in the community to provide support and receive medications. Each month one of the members will rotate visiting the clinic for their routine medical visit and will pick up medications for the entire CAG and bring them back to the community. This rotation schedule will recur every six months. Lay health care workers will provide brief symptom screening to identify patients in the group that need of higher-level care.

Other: CAG

CAG (comparison)

ACTIVE COMPARATOR

Eligible patients at control sites will be approached for willingness to participate in the study. Those who are willing will be enrolled in the study and consent will be obtained to use patient data within SmartCare to evaluate the primary outcome of retention.

Other: CAG

UAG (intervention)

EXPERIMENTAL

Urban sites will be eligible for the UAG model in which patients will be joined into a UAG group consisting of 30 people. Each UAG group will meet every two to three months at a designated site (either at the clinic facility or another site in the community). Patients will receive (a) group adherence counseling led by a lay HCW (b) two to three month supply of ART medications via a pharmacy tech (c) attendance record and symptom assessment. As in the CAG model, patients may be referred up-referred for care based on acute illness or patient preference. Patients will continue to visit the facility for a routine medical visit with a professional HCW every six months.

Other: UAG

UAG (comparison)

ACTIVE COMPARATOR

Eligible patients at control sites will be approached for willingness to participate in the study. Those who are willing will be enrolled in the study and consent will be obtained to use patient data within SmartCare to evaluate the primary outcome of retention.

Other: UAG

Interventions

START OTHER

Point of care testing for rapid ART initiation

START

CAG OTHER

Community Adherence Group

CAG (comparison); CAG (intervention)

UAG OTHER

Urban Adherence Group

UAG (comparison); UAG (intervention)

FAST-TRACK OTHER

Prescription refill only

FAST Track

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-positive adolescents and adults (\> 14 years of age)
• Last CD4 count (obtained within the last six months) \> 200
• Not acutely ill
• For CAGs, UAGs, and Fast-Track models: on ART for at least 6 months
• For the START model: ART naïve and meet the Zambian HIV guidelines for treatment initiation

You may not qualify if:

• For CAGs, UAGs: Inability to participate in the group activities due to cognition deficits or mental illness.
• Unable to provide consent or unwilling to participate in study
• Pregnancy

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead
• Johns Hopkins University: collaborator
• University of Alabama at Birmingham: collaborator
• University of California, San Francisco: collaborator
• American Institutes for Research: collaborator
• University of Zambia: collaborator
• Ministry of Health, Zambia: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

Centre for Infectious Disease Research in Zambia

Lusaka, 10101, Zambia

Location

Related Publications (19)

• Health ZMo. UNAIDS Country Progress Report Zambia. March 31, 2012 2012.

  BACKGROUND

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  PMID: 20687955 BACKGROUND

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  PMID: 22815862 BACKGROUND

• Jaffar S, Amuron B, Foster S, Birungi J, Levin J, Namara G, Nabiryo C, Ndembi N, Kyomuhangi R, Opio A, Bunnell R, Tappero JW, Mermin J, Coutinho A, Grosskurth H; Jinja trial team. Rates of virological failure in patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast Uganda: a cluster-randomised equivalence trial. Lancet. 2009 Dec 19;374(9707):2080-2089. doi: 10.1016/S0140-6736(09)61674-3. Epub 2009 Nov 24.

  PMID: 19939445 BACKGROUND

• Kredo T, Ford N, Adeniyi FB, Garner P. Decentralising HIV treatment in lower- and middle-income countries. Cochrane Database Syst Rev. 2013 Jun 27;2013(6):CD009987. doi: 10.1002/14651858.CD009987.pub2.

  PMID: 23807693 BACKGROUND

• Luque-Fernandez MA, Van Cutsem G, Goemaere E, Hilderbrand K, Schomaker M, Mantangana N, Mathee S, Dubula V, Ford N, Hernan MA, Boulle A. Effectiveness of patient adherence groups as a model of care for stable patients on antiretroviral therapy in Khayelitsha, Cape Town, South Africa. PLoS One. 2013;8(2):e56088. doi: 10.1371/journal.pone.0056088. Epub 2013 Feb 13.

  PMID: 23418518 BACKGROUND

• Decroo T, Koole O, Remartinez D, dos Santos N, Dezembro S, Jofrisse M, Rasschaert F, Biot M, Laga M. Four-year retention and risk factors for attrition among members of community ART groups in Tete, Mozambique. Trop Med Int Health. 2014 May;19(5):514-21. doi: 10.1111/tmi.12278. Epub 2014 Feb 12.

  PMID: 24898272 BACKGROUND

• Decroo T, Telfer B, Biot M, Maikere J, Dezembro S, Cumba LI, das Dores C, Chu K, Ford N. Distribution of antiretroviral treatment through self-forming groups of patients in Tete Province, Mozambique. J Acquir Immune Defic Syndr. 2011 Feb 1;56(2):e39-44. doi: 10.1097/QAI.0b013e3182055138.

  PMID: 21084990 BACKGROUND

• Fairall L, Bachmann MO, Lombard C, Timmerman V, Uebel K, Zwarenstein M, Boulle A, Georgeu D, Colvin CJ, Lewin S, Faris G, Cornick R, Draper B, Tshabalala M, Kotze E, van Vuuren C, Steyn D, Chapman R, Bateman E. Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial. Lancet. 2012 Sep 8;380(9845):889-98. doi: 10.1016/S0140-6736(12)60730-2. Epub 2012 Aug 15.

  PMID: 22901955 BACKGROUND

• Brennan AT, Long L, Maskew M, Sanne I, Jaffray I, MacPhail P, Fox MP. Outcomes of stable HIV-positive patients down-referred from a doctor-managed antiretroviral therapy clinic to a nurse-managed primary health clinic for monitoring and treatment. AIDS. 2011 Oct 23;25(16):2027-36. doi: 10.1097/QAD.0b013e32834b6480.

  PMID: 21997488 BACKGROUND

• Babigumira JB, Castelnuovo B, Stergachis A, Kiragga A, Shaefer P, Lamorde M, Kambugu A, Muwanga A, Garrison LP. Cost effectiveness of a pharmacy-only refill program in a large urban HIV/AIDS clinic in Uganda. PLoS One. 2011 Mar 28;6(3):e18193. doi: 10.1371/journal.pone.0018193.

  PMID: 21464895 BACKGROUND

• Selke HM, Kimaiyo S, Sidle JE, Vedanthan R, Tierney WM, Shen C, Denski CD, Katschke AR, Wools-Kaloustian K. Task-shifting of antiretroviral delivery from health care workers to persons living with HIV/AIDS: clinical outcomes of a community-based program in Kenya. J Acquir Immune Defic Syndr. 2010 Dec;55(4):483-90. doi: 10.1097/QAI.0b013e3181eb5edb.

  PMID: 20683336 BACKGROUND

• Bemelmans M, Baert S, Goemaere E, Wilkinson L, Vandendyck M, van Cutsem G, Silva C, Perry S, Szumilin E, Gerstenhaber R, Kalenga L, Biot M, Ford N. Community-supported models of care for people on HIV treatment in sub-Saharan Africa. Trop Med Int Health. 2014 Aug;19(8):968-77. doi: 10.1111/tmi.12332. Epub 2014 May 28.

  PMID: 24889337 BACKGROUND

• Rosen S, Fox MP. Retention in HIV care between testing and treatment in sub-Saharan Africa: a systematic review. PLoS Med. 2011 Jul;8(7):e1001056. doi: 10.1371/journal.pmed.1001056. Epub 2011 Jul 19.

  PMID: 21811403 BACKGROUND

• Rasschaert F, Telfer B, Lessitala F, Decroo T, Remartinez D, Biot M, Candrinho B, Mbofana F, Van Damme W. A qualitative assessment of a community antiretroviral therapy group model in Tete, Mozambique. PLoS One. 2014 Mar 20;9(3):e91544. doi: 10.1371/journal.pone.0091544. eCollection 2014.

  PMID: 24651523 BACKGROUND

• Hickey MD, Salmen CR, Omollo D, Mattah B, Fiorella KJ, Geng EH, Bacchetti P, Blat C, Ouma GB, Zoughbie D, Tessler RA, Salmen MR, Campbell H, Gandhi M, Shade S, Njoroge B, Bukusi EA, Cohen CR. Implementation and Operational Research: Pulling the Network Together: Quasiexperimental Trial of a Patient-Defined Support Network Intervention for Promoting Engagement in HIV Care and Medication Adherence on Mfangano Island, Kenya. J Acquir Immune Defic Syndr. 2015 Aug 1;69(4):e127-34. doi: 10.1097/QAI.0000000000000664.

  PMID: 25984711 BACKGROUND

• Bolton Moore C, Pry JM, Mukumbwa-Mwenechanya M, Eshun-Wilson I, Topp S, Mwamba C, Roy M, Sohn H, Dowdy DW, Padian N, Holmes CB, Geng EH, Sikazwe I. A controlled study to assess the effects of a Fast Track (FT) service delivery model among stable HIV patients in Lusaka Zambia. PLOS Glob Public Health. 2022 Aug 3;2(8):e0000108. doi: 10.1371/journal.pgph.0000108. eCollection 2022.

  PMID: 36962510 DERIVED

• Roy M, Bolton-Moore C, Sikazwe I, Mukumbwa-Mwenechanya M, Efronson E, Mwamba C, Somwe P, Kalunkumya E, Lumpa M, Sharma A, Pry J, Mutale W, Ehrenkranz P, Glidden DV, Padian N, Topp S, Geng E, Holmes CB. Participation in adherence clubs and on-time drug pickup among HIV-infected adults in Zambia: A matched-pair cluster randomized trial. PLoS Med. 2020 Jul 1;17(7):e1003116. doi: 10.1371/journal.pmed.1003116. eCollection 2020 Jul.

  PMID: 32609756 DERIVED

• Tucker A, Tembo T, Tampi RP, Mutale J, Mukumba-Mwenechanya M, Sharma A, Dowdy DW, Moore CB, Geng E, Holmes CB, Sikazwe I, Sohn H. Redefining and revisiting cost estimates of routine ART care in Zambia: an analysis of ten clinics. J Int AIDS Soc. 2020 Feb;23(2):e25431. doi: 10.1002/jia2.25431.

  PMID: 32064766 DERIVED

Related Links

• Frontieres MS. Community ART Group Toolkit: How to Implement the CAG Model. http://www.msf.org/sites/msf.org/files/cag\_toolkit.pdf. Accessed August 28, 2014

Study Officials

• Charles Holmes, MD, MPH

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

• Izukanji Sikazwe, MBChB

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

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: March 13, 2016
• First Posted: May 18, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 8, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)