Table 1
Definitions of implementation outcomes for the use of single-pill combination therapy (SPC) in the Hypertension Treatment in Nigeria (HTN) Program and associated quantitative and qualitative data using the RE-AIM QuEST framework.
| RE-AIM DOMAIN | MEASURES/INDICATOR | QUANTITATIVE DATASOURCE: HTN PROGRAM | QUALITATIVE DATASOURCE: FGDS AND KIIS |
|---|---|---|---|
| Reach | Intervention: Proportion of primary healthcare facilities (PHCs) selected to participate in implementing SPC that accepted to dispense SPC | Proportion of targeted PHCs that agreed to be assigned to dispense SPC | Reasons for facility participation in SPC prescribing Factors influence patients’ access to treatment with SPC |
| Effectiveness | Effectiveness of the use of SPC by trained nonphysician HCWs in BP control | BP control rates in SPC-assigned PHCs | Perception/beliefs about effectiveness of SPC |
| Adoption | HCWs dispensing SPC in assigned PHCs | Proportion of SPC-assigned PHCs that dispensed any SPC | Factors contributing to the nonphysician PHC HCWs dispensing SPC Perception/opinions and barriers/facilitators to successful adoption Role of strategies in supporting adoption |
| Strategy: Training of nonphysician HCWs on the use of a protocol-based prescription of SPC | Proportion of intervention PHCs with at least one nonphysician HCW trained on the use of SPC | Relevance of training Training needs and gaps Training approaches | |
| Implementation (fidelity) | Consistency with dispensing SPC according to protocols by HCWs | Proportion of enrolled patients in SPC-assigned PHCs who were eligible for Step 2 or 3 who received prescriptions of SPC each month | Factors contributing to the PHC nonphysician HCWs adhering to SPC protocols Barriers/facilitators to medication adherence |
| Maintenance | Continuity and long-term dispensing of SPC therapy by HCWs | Proportion of patients started on SPC who followed up on SPC within the six-month trial (patients seen and prescribed with SPC at least twice within the six months as defined in the HTN Program) | Factors contributing to the PHC nonphysician HCWs maintaining use of SPC Barriers/facilitators to maintenance of SPC use by patients (according to the nonphysician HCWs) Recommendations on sustaining SPC therapy at the facility or patient levels |
| BP control maintained above baseline in SPC assigned PHCs |
Table 2
Characteristics of qualitative study participants.
| QUALITATIVE DATA SOURCE | NUMBER OF PARTICIPANTS AND SEX DISTRIBUTION | PROFESSIONAL CADRE/ROLE | AGE DISTRIBUTION (YEARS) | YEARS OF PROFESSIONAL EXPERIENCE | ORGANIZATIONAL AFFILIATIONS |
|---|---|---|---|---|---|
| Focused Group Discussion 1 | 12 (7 females, 5 males) | 12 Community health extension workers (CHEWs) | Median: 41.5 Range: 34–54 | Median: 14 Range: 12–30 | 2 participants per area council |
| Focused Group Discussion 2 | 12 (8 females, 4 males) | 12 Nurses | Median: 52.5 Range: 40–58 | Median: 18 Range: 14–30 | 2 participants per area council |
| *Key Informant Interviews | 5 (2 females, 3 males) | Physicians: 2 (1 cardiologist, 1 public health specialist) Pharmacist: 1 Policymaker: 4 Nurse: 1 ^Community health officer: 1 | Median: 50 Range: 45–59 | Median: 25 Range: 15–33 | Primary Health Care Agency: 1 Ministry of Health: 1 Secondary health care facility: 1 Health worker regulatory bodies: 2 Professional associations: 2 |
[i] *Some key informants had multiple roles or organizations so total number of roles and organizational affiliations was more than 5.
^Community health officer (CHO) is a CHEW that has an additional one year training to gain clinical and managerial skills essential for managing a PHC as an officer in charge.
Table 3
Implementation outcomes of single-pill combination therapy implementation in the HTN program using the RE-AIM QuEST framework highlighting the quantitative and qualitative results.
| OUTCOME | MEASURES/INDICATOR | QUANTITATIVE RESULTS | QUALITATIVE RESULTS | |
|---|---|---|---|---|
| FACILITATORS | BARRIERS | |||
| Reach | Proportion of targeted primary healthcare facilities (PHCs) that agreed to be assigned to dispense SPC^ | 100% (30/30) | Availability of SPC medication at the PHCsFree SPC provision helped alleviate financial barriers and encouraged greater patient engagement | |
| Effectiveness | BP control rates in SPC-assigned PHCs** | 54% | HCW perception of good BP control due to improved adherence from patients and tolerable side effects | |
| Adoption | Proportion of SPC-assigned PHCs that dispensed any SPC^ | 100% (30/30) | HCWs welcomed the use of SPC and advocated for expanded roles in hypertension care.Ease of use and reduced pill burden of SPCs facilitated uptake | Policymakers’ concerns about nonphysicians managing more than two-drug combinations and recommend restricting their role to early hypertension stages. |
| Proportion of intervention PHCs with at least one nonphysician healthcare worker trained on the use of SPC++ | 100% (30/30) | Improved HCW capacity and confidence due to the provision of standardized treatment protocols and training on SPC | ||
| Implementation (fidelity) | HCW fidelity to prescribing SPC to eligible patients: Proportion of patients in SPC-assigned PHCs (n = 30) who were eligible and received SPC (Step 2 or 3) each month over a six-month period^ | Month 1: 21% (225/2,946) Month 2: 23% (241/2,862) Month 3: 29% (367/3,164) Month 4: 31% (337/3,080) Month 5: 34% (463/3,506) Month 6: 37% (540/3,928) | Adequate supervision and technical support facilitated adherence to protocols. | Occasional SPC stockouts, which disrupted consistent prescribing. Non-availability of multiple SPC options to cater to side effects and patient variability. Difficulty identifying which SPC component caused side effects. |
| Maintenance | Proportion of patients started on SPC who remained on SPC at the end of the 6-month cluster RCT (patients seen and prescribed with SPC at least twice within six months) | 49% (1,154/2,381) | Patients’ satisfaction and enthusiasm for SPC therapy motivated regular attendance and adherence. Potential of a drug revolving fund to sustain the supply of SPC. | Concerns that some patients may be unable to afford SPC when fee-based model is introduced. Stockouts disrupt continuity of care. |
| BP control maintained above baseline in assigned PHCs | 14% at baseline vs 54% at 6 months | |||
[i] ^ Sanuade OA, Ale BM, Baldridge AS, Orji IA, Shedul GL, Ojo TM, et al. Fixed-dose combination therapy-based protocol compared with free pill combination protocol: results of a cluster randomized trial. The Journal of Clinical Hypertension. 2023;25(2):127–136. DOI: https://doi.org/10.1111/jch.14632.
++ HTN Program reports on the training of HCWs.
**Blood pressure control at the last visit among patients who had visited a PHC twice during the study period.