Implementation fidelity conceptual framework

Opt-out HIV testing as a complex intervention

The integration of new HIV testing approach into antenatal care unit will involve several
dimensions, levels and participants (Carroll et al., 2007; Dane & Schneider, 1998;
Domitrovich, Gest, Jones, Gill, & Sanford DeRousie, 2010). It is expected that there will be
restructuring of how midwives undertake antenatal activities, and a possible restructuring of
care provision and organisational structure (Forster, Newton, McLachlan, & Willis, 2011). In
the light of this complexity, the opt-out HIV testing fits the UK Medical Research Council’s
(MRC) definition of complex intervention; comprising of multiple and inter-linking strategies
that attempt to take a ‘whole of problem’ approach to health issues (Craig et al., 2008; Medical
Research Council, 2000). Within health care setting, complex interventions are those that are
not limited to a single dose or activity, but comprise many ‘active ingredients’(Oakley, Strange,
Bonell, Allen, & Stephenson, 2006).

Implementation defined
Implementation has been defined in several ways (Carroll et al., 2007; Dane & Schneider,
1998; J. Durlak, 1998) and described with inconsistent terms (Berkel, Mauricio, Schoenfelder,
& Sandler, 2011; Dane & Schneider, 1998; J. Durlak, 1998), making ‘what’ and ‘how’ to
measure sometimes difficult. Domitrovich et al. (2010, p. 2) citing Yeaton and Sechrest (1981)
defined implementation as ‘the degree to which an intervention is followed as prescribed by
the developer…’. Durlak and DuPre (2008) on the other hand referred to implementation as
what a programme (e.g. opt-out HIV testing and counselling) consist of when it is delivered in
a particular setting. In this thesis, implementation will be referred to as how the opt-out HIV
testing policy was delivered at selected antenatal care clinics in Ghana, compared with how the
testing programme was intended to be delivered (policy intended vs policy implemented).

Implementation dimensions considered

Even though there seem to be no agreement on the dimensions of programmes to be studied
(Berkel et al., 2011; Carroll et al., 2007), most evaluators support the idea of focusing on
multiple dimensions (Carroll et al., 2007; Durlak & DuPre, 2008; Hasson, 2010). In this thesis,
implementation fidelity is evaluated using a modified framework proposed by Carroll et al.
(2007). Using this framework, the researcher adapts four common elements of implementation
fidelity:
1. Adherence to intervention design: adherence has been defined as the degree to
which implementers adhere to the intervention as intended by the intervention
designers. Carroll et al. (2007) sees adherence as the central measure of fidelity,
and therefore proposes four subcategories: content, coverage, frequency and
duration. Content denotes the ‘active ingredients’ of the intervention, i.e. the core
services that an intervention aims to deliver to intervention participants. Coverage,
frequency and duration deals with quantification of how much of the intervention’s
content was delivered to the target population (i.e. the pregnant women/partners).
2. Potential moderators: these are factors that can influence adherence to
intervention design and intervention outcome. This includes delivery quality,
participant responsiveness, facilitating strategies and adaptations.

The dimension of quality in this study will refer to how well the HIV testing and
counselling is performed, rather than just delivering the core elements (5Cs). To be
of quality, the testing and counselling service must be accessible, meets the needs
of clients and providers, conforms with recognised HTC standards (the 5Cs), has
measures in place to monitor quality of services, including external quality
assurance of the testing, and is in line with national guidelines (WHO, 2010, 2012).

Participant responsiveness
This dimension has been conceptualise as behaviour of participants in response to
intervention (Dillman et al., 2007). This proposal conceptualises four subjective
components of responsiveness: (1) participants evaluation of the intervention’s
content and how well it meets their needs, particularly their psychosocial needs (2)
pregnant women’s perception of the environment within which they received the
counselling and testing, including sense of confidentiality, trust and woman
centeredness; and (3) overall satisfaction with the programme, which may not be
specific to any single component of the content or context of the programme.

Strategies to facilitate implementation

Being a complex intervention and integrated into overburdened antenatal practice

environment, the opt-out HIV testing requires supportive approaches (WHO, 2015).
The researcher conceptualises facilitation strategies in this study as the existence of
national policies that creates an enabling environment for successful
implementation of the HIV testing guidelines. Facilitating strategies will also
 include evidence of supervision, coordination of activities at all levels, training of
staff, and existence of guidelines, manuals and testing kits. It will also involve
adequacy of the facility to implement the intervention

Adaptations

These are positive or negative additions or modifications of the intended content,

processes or methods during implementation of a programme in a natural setting
(Berkel et al., 2011; Moore, Bumbarger, & Cooper, 2013). Adopting and adapting
WHO/UNAIDS guidelines to suit local context has in fact been recommended by
the World Health Organisation (Baggaley et al., 2012; WHO/UNAIDS, 2007). No
matter the nature of adaptation, fidelity of core components of programmes must be
preserved, in order to achieve the desired outcomes stipulated by the designer of the
intervention (Hasson, 2010).

Using this framework, the researcher plans to describe the key components of the opt-out HIV
testing program as adopted in Ghana, and give insight into the degree to which Midwives and
other professionals working in the antenatal clinics adhered to the delivery of these components
(5Cs). In order to provide context and explanation to my findings, moderating factors and other
factors that may influence implementation of the intervention is described. I hope to contribute
to the existing knowledge about implementation of the opt-out HIV testing in antenatal clinic
setting, and to the assessment of fidelity of complex interventions within the field of HIV care.
 Potential moderators
1. Quality of delivery1
2. Participant responsiveness2
3. Facilitating strategies
4. Adaptations4

Adherence5
Intervention  Key components of 5Cs Outcomes
delivered Number of women accepting testing and
Opt-out HIV testing at ANC HIV positive pregnant women linked to
 Exposure or dose care
 Duration

Evaluation
Evaluation of
implementation
fidelity

Programme differentiation;
To identify ‘essential’ components

Definition of terms

1. Quality of delivery: the manner in which midwives delivered the core components of the opt-out HIV testing program
2. Participant responsiveness: how pregnant women and health care providers responded to, or were engaged in the intervention
3. Exposure or dose: the amount of an intervention received by the participants (both health care providers and pregnant women)
a. Frequency and duration of intervention: whether all elements of the intervention were delivered as often as specified
b. Coverage: whether all the people who should be participating in or receiving the benefits of the intervention did so
4. Adherence: Whether the 5Cs in the opt-out HIV testing is being implemented as it was intended by WHO/UNAID
5. Programme differentiation: identifying which elements of the opt-out testing intervention are important without which the program will not have its intended effect

Modified conceptual framework for fidelity of implementation by Carroll et al. (2007)

The objectives of the proposed these are:

1. To document how the opt-out HIV testing policy has been implemented in Ghana,
including facilitating strategies put in place to ensure smooth delivery of the program
2. To explore nurses’ and midwives’ adherence to the opt-out HIV testing program
guidelines.
3. To explore the quality of programme delivery, including adaptations made to the
core components of the program during implementation.
4. To explore the participant responsiveness in terms of pregnant women’s satisfaction
with the content of pre-test information and counselling and intervention delivery.
5. To explore health care provider’s engagement with the program, including perceived
implementation facilitators and barriers when implementing the program.
Research questions
1. What measures have been put in place at the national, regional and local level to
facilitate smooth implementation of the opt-out testing programme? (facilitating
strategies)
2. To what extent are midwives in each clinic performing HIV testing and counselling
according to written opt-out HIV testing guidelines? (adherence to core content of
5Cs)
3. What adaptations are made to the core components of testing protocol during
implementation? (adaptations)
4. What is the quality of testing and counselling services provided in the selected
facilities?(quality of delivery)
5. How did nurses and midwives experience the intervention, in terms of perceived
barriers and facilitators? (participant response)
6. How did pregnant women experience the intervention, in terms of quality of delivery,
being respected and confidentiality maintained? (participant response)

Identifying key indicators and research questions

Key indicators are the active ingredients or program component that must be implemented

with fidelity in order for the intervention to be successful. Identification of these indicators

and related research questions was done using the DoView program. Identitified indicators

have been summarised in the table below

Evaluation Sub-categories Research questions Key indicators Tools Data type Data sources
dimension
Women informed of Observation Structured observation Testing and counselling
Obtaining informed Did pregnant women give informed consent  benefits of HIV testing to the mother, child & partner checklist sessions
Consent (pre-test for HIV testing?  what it means to test positive Informal observation and
Adherence to the information giving)  risk of HIV infection to the infant & measures to reduce MTCT Field notes conversation of clinic HCPs,
5Cs  services available in case of a positive diagnosis staff Pregnant women
 preventive options & need for partner testing Survey questionnaire
 confidentiality, right to refuse test & opportunity to ask questions Semi-structure interview
 Using approved test kits, reagents (e.g. rapid or ELISA) Observation Structured observation Structured observation
Correct results Was correct procedure followed in testing  Positive test results confirmed with a 2nd antibody test checklist Informal observation and
pregnant women?  Discordant results followed by a 3rd test, using venous blood Informal observation and conversation of clinic staff
 Retesting of at risk but negative clients after 3 months Field notes conversation of clinic Semi-structure interview
 Evidence of storage of test kits at optimal temperature staff
 Evidence of minimum stock of 1 month’s needs available Survey questionnaire
Semi-structure interview
 Evidence of quality assurance mechanisms
 Retesting women testing positive
Post-test Counselling Was testing performed in line with  Test given in simple, clear language and mothers given time to consider it Observation Structured observation Structured observation
established guidelines?  Ensuring that mothers understand test result checklist Informal observation and
 Help mothers cope with emotions arising from test result Informal observation and conversation of clinic staff
 Allow mothers to ask questions Field notes conversation of clinic Semi-structure interview
 Assess the risk of violence or suicide & manage staff
 Address any immediate concerns Survey questionnaire
 Provide information on how to prevent transmission of HIV Semi-structure interview
Connection to care What measures were taken to ensure that  Provide information on other relevant preventive health measures such as Exit interview Structured observation Structured observation
(linkage) women who tested positive have been good nutrition
linked to care?  Discuss possible disclosure of the result, when and how this may happen and Focus group Informal observation and Informal observation and
to whom discussion conversation of clinic conversation of clinic staff
 Encourage and offer referral for testing & counselling of partners and staff
children Survey questionnaire Semi-structure interview
 Describe follow-up services available in the health facility & in the Semi-structure interview
community
 Discusses childbirth plans, mothers nutrition and infant feeding options
 Discusses importance of ART to mother and unborn child
 HIV testing for the infant and the follow-up that will be necessary
Confidentiality Were measures taken to ensure that testing  HIV testing and counselling rooms are private and adequately sound proof Observation Structured observation Structured observation
is confidential?  Confidential filing system in place for client medical records/HTC records checklist Informal observation &
 Informal observation & conversation of clinic staff
Field notes conversation of clinic Semi-structure interview
staff
Survey questionnaire Semi-structure interview
Potential Are there evidence of policies and  Evidence of existence of policies on confidentiality, voluntary and informed Checklist Key informant interview
moderators monitoring framework that ensure smooth consent, correct testing, and linkage to care Interview guide Document review
implementation of the policy?  Evidence of evaluation framework and quality assurance for the opt-out HIV
Availability of testing
facilitating strategies Are there evidence guidelines, protocols  Evidence of guidelines on qualification, training and supervision of midwives Checklist Clinic resource audit
and physical space at antenatal clinics that  Guidelines on pre-test information given, post-test counselling, linkage to Interview guide Key informant interview
ensures HIV testing in a confidential care, quality assurance plan for test kits
manner?  Guidelines specifying methods for evaluation
 What are the gaps in the training, resources,
supervision, motivation and workload
among health care providers at antenatal
clinics where HIV testing and counselling
is conducted?
 Training in HIV counselling and testing
 Support and supervision provided
 HIV testing process and challenges encountered
 Health care provider work condition and work load
 Evidence of psychological burnout

What adaptations (negative, positive and Modifications made to (1) Offer of pre-test information (2) HIV testing Observation Semi-structured T & C sessions
Adaptations neutral) were made to the core components (3) Post-test counselling and (4) Linkages to care checklist Interview observation Health care providers
at the point of delivery? guide Focus group discussion

To what extent were the essential elements  Evidence that testing was carried in a way that (1) respected the dignity of Interview guide FGDs
Quality of delivery (5Cs) implemented with quality? pregnant women (2) woman centred (4) empowering questionnaire
 Communication skills, rapport building
 Nurse-patient interactions
 Enthusiasm of nurse
Participant How did health care providers respond to Pregnant women Survey questionnaire Semi-structured Pregnant women
responsiveness testing intervention in terms of barriers,  Experience with the entire testing experience interviews ( pregnant
facilitators, workload and training needs? Interview guide women and health care Health care providers
Field notes providers
What were the level of participation and
satisfaction in the testing and counselling Health care providers Exit interviews (pregnant
programme among pregnant women?  Perceived barriers and enablers of the intervention women)
Baggaley, R., Hensen, B., Ajose, O., Grabbe, K., Wong, V., & Schilsky, A. (2012). From caution to
urgency: the evolution of HIV testing and counseling in Africa. Bull World Health Organ, 90.
doi: 10.2471/blt.11.100818
Berkel, C., Mauricio, A. M., Schoenfelder, E., & Sandler, I. N. (2011). Putting the pieces together: an
integrated model of program implementation. Prev Sci, 12(1), 23-33. doi: 10.1007/s11121-
010-0186-1
Carroll, C., Patterson, M., Wood, S., Booth, A., Rick, J., & Balain, S. (2007). A conceptual framework
for implementation fidelity. Implementation Science, 2(1), 40. doi: 10.1186/1748-5908-2-40
Craig, P., Dieppe, P., Macintyre, S., Michie, S., Nazareth, I., & Petticrew, M. (2008). Developing and
evaluating complex interventions: the new Medical Research Council guidance. Br Med J,
337. doi: 10.1136/bmj.a1655
Dane, A., & Schneider, B. (1998). Program integrity in primary and early secondary prevention: Are
implementation effects out of control. Clin Psychol Rev, 18. doi: 10.1016/s0272-
7358(97)00043-3
Dillman, C., R., F., Mauricio, A. M., Gonzales, N. A., Millsap, R. E., Meza, C. M., . . . Genalo, M. T.
(2007). Engaging Mexican Origin Families in a School-Based Preventive Intervention. J Prim
Prev, 28(6), 521-546. doi: 10.1007/s10935-007-0110-z
Domitrovich, C. E., Gest, S. D., Jones, D., Gill, S., & Sanford DeRousie, R. M. (2010). Implementation
Quality: Lessons Learned in the Context of the Head Start REDI Trial. Early childhood research
quarterly, 25(3), 284-298. doi: 10.1016/j.ecresq.2010.04.001
Durlak, & DuPre, E. (2008). Implementation Matters: A Review of Research on the Influence of
Implementation on Program Outcomes and the Factors Affecting Implementation. American
journal of community psychology, 41(3-4), 327-350. doi: 10.1007/s10464-008-9165-0
Durlak, J. (1998). Why programme implementation is so important. J Prev Interv Community, 17. doi:
10.1300/J005v17n02_02
Forster, D. A., Newton, M., McLachlan, H. L., & Willis, K. (2011). Exploring implementation and
sustainability of models of care: can theory help? BMC Public Health, 11(Suppl 5), S8-S8. doi:
10.1186/1471-2458-11-S5-S8
Hasson, H. (2010). Systematic evaluation of implementation fidelity of complex interventions in
health and social care. Implementation science : IS, 5, 67-67. doi: 10.1186/1748-5908-5-67
Medical Research Council. (2000). 0A framework for the development and evaluation of RCTs for
complex interventions to improve health. London.
Moore, J. E., Bumbarger, B. K., & Cooper, B. R. (2013). Examining adaptations of evidence-based
programs in natural contexts. J Prim Prev, 34(3), 147-161. doi: 10.1007/s10935-013-0303-6
Oakley, A., Strange, V., Bonell, C., Allen, E., & Stephenson, J. (2006). Process evaluation in
randomised controlled trials of complex interventions. Br Med J, 332. doi:
10.1136/bmj.332.7538.413
WHO. (2010). A Handbook for Improving HIV Testing and Counselling Services. Geneva.
WHO. (2012). SERVICE DELIVERY APPROACHES TO HIV TESTING AND COUNSELLING (HTC): A
STRATEGIC HTC PROGRAMME FRAMEWORK.
WHO. (2015). Consolidated guidelines on HIV testing services.
WHO/UNAIDS. (2007). Guidance on provider-initiated HIV testing and counselling in health facilities.
Geneva: Retrieved from http://www.who.int/hiv/pub/vct/pitc2007/en/.
Yeaton, W. H., & Sechrest, L. (1981). Critical dimensions in the choice and maintenance of successful
treatments: Strength, integrity, and effectiveness. Journal of Consulting and Clinical
Psychology, 49(2), 156-167. doi: 10.1037/0022-006X.49.2.156