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Toolkit for Implementing and Evaluating Differentiated Service Delivery Models to Improve HIV Treatment Outcomes
In this section we provide an overview on how to implement community-based group (CAG), facility-based group (UAG or Medication Adherence Clubs), and facility-based individual (Fast Track and START) models. Learn more
For each model we present preparatory steps, predictors of success, and tips on implementation based on our field experiences, qualitative research methods and staff workshops.
Overall, we found that regardless of the specific model, the following elements are essential to successful implementation:
Guidance on how to assess whether a country or facility meet the requirements for successful implementation of DSD models are available at the C-QUIN and Differentiated Care websites.
Below we describe the preparatory steps we took to implement CAGs in Zambia. Other examples can be found at the Differentiated Care, Global Fund and CQUIN websites.
Leadership and Governance through Ministry of Health at national, provincial, district and facility levels as well as current ART guidelines were critical to successful implementation. Facility and ART in-Charges particularly played a big role providing oversight, input to system-design (space, patient flow, filing, human resources, troubleshooting), holding involved personnel accountable and sensitizing communities on DSD.
Stakeholder sensitization was critical before setting up the study as it would be for any programme launch. Key stakeholders for CAGs in Zambia included the Ministry of Health, health care workers, patients, community members and leaders, and chiefs. Stakeholders were engaged pre-implementation, at launch, and throughout implementation until study completion to communicate plans, report progress, and seek feedback. Communication continued after the study to share study findings. [See sensitization materials]
Health service delivery had to take into consideration
We included people > 14 years old, not acutely ill, and on ART for at least the past 6 months. The eligibility criteria of CD4 count >200 was difficult to implement because of erratic testing and filing of laboratory results. We relied on clinician’s judgement of stability where there was no CD4 test result in the last 6 months on record.
Some patients were not interested in joining the CAG model because of self-stigmatization (they felt they would be too visible), moving from 3-months drug supply already in place to monthly collection by CAG members, and in very early cases, symbolism of the recurring number six -- 6 members, 1 clinic visit at 6 months, and the second again after 6 months (666 symbolises satan). The last was managed through community sensitization by the ART in-charge.
Patients who lived in sparsely populated and remote areas or who did not know others on ART could not form CAGs of 6. CAGs needed at least one literate person to successfully complete symptom checks and meeting registers.
Since patients were only given a month’s supply for each group member, having less than 6 members meant some patients could have more than 2 visits a year. More than 6 members meant that sometimes a member was never assigned for ART pick-up.
Though patients had no concerns regarding privacy and confidentiality, they had to be provided with pre-packaged ART and backpacks to transport the ART back and forth (if any not distributed) between the facility and community. Documentation on meeting attendance, symptom checks and receipt of ART was also required. Though not experienced, insufficient literacy could make distribution difficult if packaging changed or two or more patients were on differing ART regimens.
Distributing ART in the community requires a pharmacy supply chain that can handle multi-month refills. The dispensers have to rearrange their documentation and work flow, recognize when a CAG member is due for a group ART pick-up, and to allow time to pre-pack medicines for the CAG group. Similarly, time has to be allocated to complete the pharmacy register when information on ART distribution is received from the CAG leader.
Patient files can be grouped by CAG. However, they have to be filed for easy retrieval of individual files for unscheduled visits. In our case, we wrote the CAG identification number on the patient card. If not grouped by CAGs, there needs to be an easy system to identify files per CAG – for instance file colour or linking file.
If a CAG member required additional special clinical visits due to illness, the HCW Supervisor would communicate with the clinician and other clinic staff after every visit to determine the status of the patient and whether they will continue receiving medications through the CAG or through alternative measures at the clinic. The HCW supervisor would communicate with the lay HCW regularly to adjust the clinic visit schedule and medication pick-up for the entire CAG accordingly.
If a CAG member was being permanently up-referred, they would continue to receive 1-month supply of medications at CAG meetings until they were linked back into routine care.
Once the clinician determined that additional care was not necessary for a CAG member, they were referred back to the Lay HCW who worked with the patient to return them to the CAG and related routine.
Monitoring tools can be found under the resources tab. These include the CAG Group Membership Register that provides place, date of joining and date of leaving the CAG; the CAG Meeting Attendance Register records attendance and presence and absence of various signs of illness (e.g., night sweats); the CAG Event Form documents illness, hospitalization, absence from meeting, failure to collect ART and disputes, along with actions taken to address these.
Health workforce Lay Health Care Workers were critical in supporting CAGs. They provided orientation to newly formed CAG groups and ongoing support to CAGs with ill or pregnant members in need of up-referral to the facility as well as to help resolve disputes within CAGs. They received any uncollected drugs from the group leader after CAG meetings and ensured that data clerks received accurate pharmacy ARV pick-up data.
Essential medical products Patients only received their prescribed ARVs through this system. They were required to visit the clinic to collect drugs for any acute or chronic conditions.
Space and Infrastructure did not need remodeling except to ensure that the pharmacy had enough space to store prepackaged drugs.
Laboratory services Patients received laboratory services during their clinical visits.
The Zambian Ministry of Health insisted on Zambia-specific evidence on implementation, health outcomes and scalability of DSD. Community leadership were acutely aware of the burden of HIV and related care to communities, families, patients and health systems. This advocacy made it possible for facilities to allow the study and for patients to consider participation.
Lay HCWs supported up to 15 CAGs. Transportation (via bicycles) was necessary to cover the distance between meeting location and facility or to ensure timely arrival to CAG meetings held on the same day and different locations.
Most groups were self-forming (74 of 84 groups) and consisted of nuclear and extended family members. Not wanting to risk disclosure beyond their known circle, some groups had less than 6 members. In some remote areas, there were only 3 patients who lived in close enough proximity to each other to hold CAG meetings. In a few cases, 7-8 nuclear and extended family members formed a group. In total, 29 (35%) groups adapted group size from intended size of six (range: 3- 8). Groups formed in a fishing village preferred to continue receiving 2-3 months of ARVs to accommodate their migrant work rather than receive only one month’s supply of ARV.
Each group had to commit to a shared group code of conduct to maintain positive group dynamics. This was achieved at the time the group was formed through mutual agreement on what the code of conduct should include. This allowed groups to remind members regarding expected and mutually agreed upon conduct. For instance, one group had to remind a member who was indiscrete when under the influence of alcohol about the need to maintain confidentiality.
Some groups formed cooperatives for income generation or pooled money each month to cover transport costs for the person going to the clinic to complete their clinical visit and to collect the ARVs.
It was easier to synchronise clinical visits with ART pick-up for groups of 3 and 6. Smaller groups required some members to make an additional trip just to pick up ART for the group. In a larger group, more than one member had to attend their 6-monthly clinical visit in a month. [See example]
For the smallest groups (of 3) patient visits were reduced to 4 in a year as opposed to 12 in routine care. Other options should be explored. For instance, if there are 4 members, perhaps 3 months ART supply can be issued at a member’s clinical visit.
An adequate drug supply and storage space, perhaps because patients continued to receive 1 month of ARVs, along with provision of a carrier bag allowed successful pre-packaging and dispensation of drugs within CAGs.
CIDRZ ACHIEVE project scaled up CAGs to form 818 CAGs of stable patients. They noted that:
System flexibility is required to accommodate patient preference for specific meeting times, including weekends. Though we did not organize groups by age, sex, or marital status and received no complaints from group members, these patient characteristics may need to be considered when forming UAGs.
UAG patients’ preference for weekends could increase costs in facilities normally closed on weekends due to required staff compensation and security measures. This weekend surge in patient load also increased pharmacy workload on Fridays and for data clerks on Monday. Some patients arrived late for UAG meetings, others asked many questions during health talks, while still others stayed back to socialize, all which lengthened meeting times from the planned 1 hour to up to 4 hours. During interviews, health care workers recommended appropriate staff scheduling to prevent fatigue and compensation for working off-hours and weekends to prevent staff burnout.
Some UAG patients chose to pick their ART during their clinical visit and miss their UAG meeting. Other patients chose to attend or send a buddy to a UAG meeting to obtain their ARVs but missed their routine clinical visit which was provided during normal working hours. Having a nurse or clinical officer to provide 6-monthly clinical review, manage illnesses and other needs during UAG meetings could meet patient needs and further decongest facilities.
Some UAG members forgot their meeting dates. Visit reminders including for clinical visits as well as a buddy system could help UAG members access services as scheduled. Allow patients to call to make appointments in case they cannot attend a UAG meeting due to unforeseen circumstances.
While facilities accommodated the DSD models, competing priorities and new programmes could easily displace staff, equipment and supplies. The fundamental health system challenge of infrastructure and space were not resolved. For instance, some dilapidated spaces did not provide adequate protection from the elements or pests.
Facilities helped each other with ART and so never experienced drug shortages unless it was country-wide. If the expiry date was between 2-3 months, then UAG meeting dates had to be adjusted accordingly and communicated to patients including those absent on the day of dispensation.
Below we describe the preparatory steps we took to implement a facility based group model UAG -- in Zambia. Other examples can be found at the Differentiated Care website.
Leadership and Governance We considered current ART guidelines and secured the support of Ministry of Health at national, provincial, district and facility levels. Facility and ART in-Charges were particularly critical to successful implementation to assure effective oversight, attention to system-design, and accountability.
Stakeholder sensitization Sensitization was critical before setting up the study. For UAG, it was important that patients understood that they could choose from a selection of days and times but could not choose their group members.
Key stakeholders for facility-based group models included the Zambian Ministry of Health, health care workers, patients, community members and leaders, and chiefs. Stakeholders were engaged pre-implementation, at launch, and throughout implementation until study completion to communicate plans, report progress, and seek feedback. Communication continued after the study to share study findings. Sensitization materials
Delivery of UAG-related services had to take into consideration:
We included people > 14 years old, not acutely ill, and on ART for at least the past 6 months. The eligibility criteria of CD4 count >200 was difficult to implement because of erratic testing and filing of laboratory results. We relied on clinician’s judgement of stability where there was no CD4 test result in the last 6 months on record.
Some patients were not interested to join the UAG model because of self-stigmatization (they felt they would be too visible).
Distributing ART to UAGs requires a pharmacy supply chain that can handle multi-month refills. The dispensers have to rearrange their documentation and work flow in order to anticipate and prepare for UAG meetings. They have to allow time to pre-pack medicines for all UAG group meetings scheduled for the next day. The pharmacy register needs to be available to record ART pick-up.
Patient files can be grouped by UAG. However, they need to be filed for easy retrieval for unscheduled visits. In our case, we wrote the UAG identification number on the patient card. If not grouped by UAGs, there needs to be an easy system to identify files per UAG – for instance file colour or linking file.
If a UAG member required additional special clinical visits due to illness, the HCW Supervisor would communicate with the clinician and other clinic staff after every visit to determine the status of the patient and whether they will continue receiving medications through the UAG or through alternative measures at the clinic. The HCW supervisor would communicate with the lay HCW regularly to adjust the patient’s clinic visit schedule and medication pick-up accordingly.
If a UAG member was being permanently up-referred, they would continue to receive 2 to 3-months supply of ART at UAG meetings until they were linked back into routine care.
Once the clinician determined that additional care was not necessary for a UAG member, they were referred back to the Lay HCW who worked with the patient to return them to their UAG and related routine.
Monitoring tools can be found in the appendices of the UAG training materials under resources. These include the UAG Group Membership Register that provides place, date of joining and date of leaving the UAG; the UAG Meeting Attendance Register records attendance and presence and absence of various signs of illness (e.g., night sweats); the UAG Event Form documents illness, hospitalization, absence from meeting, failure to collect ART and disputes, along with actions taken to address these.
Health workforce Pharmacy Technicians had to be available to serve during off-hour UAG meetings. Lay Health Care Workers were critical to pulling out patient files in anticipation of visits, helping to prepackage drugs and in completing symptom checks. A nurse facilitated health talks during UAGs. See toolkit SOPs
Essential medical products Patients only received their prescribed ARVs through this system. They were required to visit the clinic pharmacy to collect drugs for any acute or chronic conditions.
For UAGS, space had to be arranged for patients to be able to meet at the facility during off-hours and weekends. In addition, a secure place was needed to store pre-packaged drugs.
Laboratory services As with CAGs, patients received laboratory services during their clinical visits.
Monitoring and Evaluation and Research and Learning (MERL) See monitoring and research tools.
The Zambian Ministry of Health insisted on Zambia-specific evidence on implementation, health outcomes and scalability of DSD. Community leadership were acutely aware of the burden of HIV and related care to communities, families, patients and health systems. This advocacy made it possible for facilities to allow the study and for patients to consider participation.
Facilities that did not have rooms or covered outdoor spaces that could accommodate groups as large as 30 allowed the team to set up tents. It was possible to secure pre-packaged drugs at the pharmacy as the Pharmacy Technician had keys to the room. Where such an arrangement was not possible, the ART and facility in-Charges provided alternatives, such as the maternity ward for storing pre-packaged in the day preceding the UAG.
Pharmacy Technicians appreciated having the luxury of time to engage in-depth with patients to understand their ART experience rather than simply dispensing drugs through the pharmacy window.
The ART in-charge ensured availability of staff, ARTs and space for several back-to-back UAG meetings to accommodate patient preference for weekend UAG meetings.
UAGs consisted of relatively large mixed-sex groups mostly strangers Still, during focus group discussions, UAG members did not suggest smaller groups or alternate group composition.
System flexibility is required to accommodate patient preference for specific meeting times, including weekends. Though we did not organize groups by age, sex, or marital status and received no complaints from group members, these patient characteristics may need to be considered when forming UAGs.
UAG patients’ preference for weekends could increase costs in facilities normally closed on weekends due to required staff compensation and security measures. This weekend surge in patient load also increased pharmacy workload on Fridays and for data clerks on Monday. Some patients arrived late for UAG meetings, others asked many questions during health talks, while still others stayed back to socialize, all which lengthened meeting times from the planned 1 hour to up to 4 hours. During interviews, health care workers recommended appropriate staff scheduling to prevent fatigue and compensation for working off-hours and weekends to prevent staff burnout.
Some UAG patients chose to pick their ART during their clinical visit and miss their UAG meeting. Other patients chose to attend or send a buddy to a UAG meeting to obtain their ARVs but missed their routine clinical visit which was provided during normal working hours. Having a nurse or clinical officer to provide 6-monthly clinical review, manage illnesses and other needs during UAG meetings could meet patient needs and further decongest facilities.
Some UAG members forgot their meeting dates. Visit reminders including for clinical visits as well as a buddy system could help UAG members access services as scheduled. Allow patients to call to make appointments in case they cannot attend a UAG meeting due to unforeseen circumstances.
While facilities accommodated the DSD models, competing priorities and new programmes could easily displace staff, equipment and supplies. The fundamental health system challenge of infrastructure and space were not resolved. For instance, some dilapidated spaces did not provide adequate protection from the elements or pests.
Facilities helped each other with ART and so never experienced drug shortages unless it was country-wide. If the expiry date was between 2-3 months, then UAG meeting dates had to be adjusted accordingly and communicated to patients including those absent on the day of dispensation.
Below we describe the preparatory steps we took to implement facility based individual models – FastTrack – in Zambia. Other examples can be found at the Differentiated Care website.
Leadership and Governance We considered current ART guidelines and secured the support of Ministry of Health at national, provincial, district and facility levels. Facility and ART in-Charges were particularly critical to successful implementation to assure effective oversight, attention to system-design, and accountability.
Stakeholder sensitization Sensitization was critical before setting up the study. For FastTrack, key stakeholders included the Zambian Ministry of Health, health care workers, patients, community members and leaders, and chiefs. Stakeholders were engaged pre-implementation, at launch, and throughout implementation until study completion to communicate plans, report progress, and seek feedback. Communication continued after the study to share study findings. Sensitization materials
Delivery of services had to take into consideration:
We included people > 14 years old, not acutely ill, and on ART for at least the past 6 months. The eligibility criteria of CD4 count >200 was difficult to implement because of erratic testing and filing of laboratory results. We relied on clinician’s judgement of stability where there was no CD4 test result in the last 6 months on record.
ART distribution and symptom checks were conducted in a dedicated treatment room. Distributing 3-months of ART requires a pharmacy supply chain that can handle multi-month refills. The dispensers have to rearrange their documentation and work flow, know when a FastTrack patient is due for ART pick-up, and allow time to pre-pack medicines for all FastTrack patients scheduled on the next day. Similarly, time has to be allocated to complete the pharmacy register when information on ART distribution is received from the FastTrack treatment room.
We maintained FastTrack patient files in the dedicated treatment room. However, if the registrar was unaware that the patient belongs to FastTrack, they created temporary files. In our case, we maintained a list of FastTrack files at the registry. However, retrieval was not always easy as the files could be in process at pharmacy, laboratory, clinical review or data entry.
If a FastTrack patient required additional special clinical visits due to illness, the HCW Supervisor would communicate with the clinician and other clinic staff after every visit to determine the status of the patient and whether they will continue receiving medications through the dedicated treatment room or through alternative measures at the clinic. The HCW supervisor would communicate with the lay HCW regularly to adjust the clinic visit schedule and medication pick-up for the patient accordingly.
If a FastTrack patient was being permanently up-referred, they would continue to receive 3-months supply of medications until they were linked back into routine care.
Once the clinician determined that additional care was not necessary for a FastTrack patient, they were referred back to the Lay HCW who worked with the patient to return them to the FastTrack routine.
Monitoring tools include the FastTrack Enrolment Register that provides place and date of joining, first ART pick-up and of the first two clinic visits. The FastTrack Attendance Register records attendance, presence and absence of various signs of illness (e.g., night sweats), and date of next visit.
The Zambian Ministry of Health insisted on Zambia-specific evidence on implementation, health outcomes and scalability of DSD. Community leadership were acutely aware of the burden of HIV and related care to communities, families, patients and health systems. This advocacy made it possible for facilities to allow the study and for patients to consider participation.
With space such a premium, some facilities had to sacrifice space, for instance staff kitchen, to make space for a FastTrack room. In such cases, ART and facility in-Charges had to identify alternative locations to store pre-packaged drugs.
Pharmacy Technicians appreciated having the luxury of time to engage in-depth with patients to understand their ART experience rather than simply dispensing drugs through the pharmacy window. Patients also reported feeling ‘special’ because of this attention.
Lay HCWs reported that FastTrack reduced friction with patients who previously would fight over waiting times. Patients reported feeling special while accessing the dedicated room devoid of queues and long waiting times.
Though FastTrack required a separate room and dedicated staff, it was the least disruptive to existing systems for clinic flow, laboratory and pharmacy activities, filing and data entry.
The practice of informal payment for expedited services and of facilitating processes for known persons is called FastTrack in Zambia. Hence, there was some concern that the FastTrack model would expose HCWs to accusations of favoritism, nepotism and corruption.
Without appropriate sensitization and awareness, rapid and dedicated pharmacy services for FastTrack patients can be misunderstood as favoritism and corruption.
While facilities accommodated the DSD models, competing priorities and new programmes could easily displace staff, equipment and supplies. The fundamental health system challenge of infrastructure and space were not resolved. For instance, some dilapidated spaces did not provide adequate protection from the elements or pests.
Facilities helped each other with ARVs and so never experienced drug shortages unless it was country-wide. If the expiry date was within 3 months, then FastTrack patients had to return earlier than the proposed 3 months.
FastTrack patients, particularly migrant and transport workers, presented earlier or later than scheduled depending on their work schedule. This meant that staff were not prepared with requisite files, ART supply and reporting and recording tools.
Visit reminders including for clinical visits could help FastTrack members receive services as scheduled. Patients should have a number to reschedule appointments in case they cannot attend a FastTrack visit due to unavoidable circumstances.
Specific weekdays could be set aside to implement FastTrack and expedite clinical visits. Alternatively, for FastTrack, on days where drug collection coincides with clinical visit, patients should see clinician prior to drug collection.
Below we describe the preparatory steps we took to implement START in Zambia. Other examples can be found at the Global Fund and Organization for Public Health Interventions and Development websites.
Leadership and Governance We incorporated current ART guidelines and secured the support of Ministry of Health at national, provincial, district and facility levels to streamline processes. Facility and ART in-Charges were particularly critical to successful implementation to assure effective oversight, attention to system-design, and accountability.
Stakeholder sensitization Sensitization was critical before implementing START in the pre- universal test and treat era. For START, it was important that patients understood that whether they could be initiated on ART ultimately depended on clinician’s judgement. It was also important that communities were aware that there may not be lag time between diagnosis and treatment. Key stakeholders for START included the Zambian Ministry of Health, health care workers, patients, community members and leaders, and chiefs. Stakeholders were engaged pre-implementation, at launch, and throughout implementation until study completion to communicate plans, report progress, and seek feedback. Communication continued after the study to communicate viral load results and other study findings. Sensitization materials
Delivery of services had to take into consideration:
We included people > 14 years old, not acutely ill, testing HIV positive, CD4 count <500 at point of care testing with PIMA or otherwise eligible for ART initiation per national guidelines. Pregnant women were not enrolled into START. They were directed to maternal and child services as per national guidelines.
Alere, the manufacturer, provided technical support and replacement machines to address malfunctions.
Health workforce Nurses were trained in using the PIMA machine to get point-of-care CD4 counts and adherence counselors in providing intensified adherence counseling. SOPs
Space and Infrastructure To ensure efficiency, all services for streamlined ART initiation needed to be available in close proximity. These services included POC CD4 testing, assessing eligibility to initiate ART, intensified adherence counseling, laboratory specimen collection and ART initiation.
Laboratory services Patients received laboratory services at enrolment and as per national guidelines at the clinic.
The Zambian Ministry of Health insisted on Zambia-specific evidence on implementation, health outcomes and scalability of DSD. Community leadership were acutely aware of the burden placed on patients newly diagnosed with HIV because of multiple trips and assessments required before initiation, which put them at risk of developing opportunistic infections. This advocacy made it possible for facilities to allow implementation and for patients to consider participation.
Though not so pertinent for ART initiation in the era of universal test and treat, CD4 counts are still important for clinical management of HIV patients. Provision of point of care CD4 testing allowed initiation of eligible patients, usually within the space of two days. However, malfunctions in the PIMA machine and inadequate mastery on how to resolve common errors could delay CD4 test results. Having a staff member well versed in common errors and setting up reciprocal arrangements with neighbouring clinics was important to ensure continuity of services.
In interviews conducted 12 months after enrolment, patients recalled being appreciative of being initiated within a day or two of eligibility. Early initiation addressed their fear of getting sick and the burden of multiple pre-initiation visits. Some went as far as to encourage their partners, family and friends to test for HIV in anticipation of rapid ART initiation if eligible.
With START, choice of rooms was less flexible because services needed to be located in proximity of each other. Intensified adherence counseling meant that the counseling room was occupied for a longer period of time. More rooms were needed to provide multiple concurrent intensified adherence counseling sessions.
Lay health care workers were nervous about the time required and their ability to assess patient readiness for ART initiation. They were concerned that patients would be started before they had time to fully comprehend their HIV status and the requirements of ART regimens. We assured them that their assessment of readiness would determine initiation – and if uncertain, initiation could be delayed.
The most common reasons given by patients for refusing ART initiation were the common understanding that same day testing and ART initiation was not possible. Other reasons were related to self- and perceived stigma. Linkage registers would be helpful to track refusal and to provide counseling and support patients need to make informed health decisions.
Some clinicians were uncomfortable initiating patients on ART without consulting the full complement of laboratory results. We asked clinicians to use their best clinical judgement while being cognizant of the precedent set by Option B+ for START. Simultaneously, laboratories were encouraged to have a quick turn-around time to make the full complement of laboratory results available as soon as possible.
Sometimes clinicians were absent from clinic. Patients eligible by HIV test and CD4 count were rescheduled to return the next day for clinicians’ recommendation on ART initiation. Clinicians rosters could help ensure coverage for timely ART initiation.
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