Implementation of point-of-care screening for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis among pregnant women in South Africa: a mixed-methods process evaluation of the Philani Ndiphile trial

This mixed-methods process evaluation of the Philani Ndiphile trial in South Africa demonstrates that while point-of-care screening for curable STIs among pregnant women achieved high uptake and treatment coverage, successful scale-up into routine care is currently hindered by operational constraints such as electricity dependence, turnaround time, and workforce limitations, necessitating strengthened health system capacity and faster diagnostics.

The Gist

Imagine you are running a busy bakery (a prenatal clinic) in a town where a hidden, invisible mold (sexually transmitted infections like Chlamydia, Gonorrhea, and Trichomonas) is ruining the bread (the babies) before anyone even knows it's there.

For years, the bakery's rule was: "If the bread looks okay, it's fine. If it smells bad, we fix it." This is called syndromic management. But here's the problem: this invisible mold often doesn't smell or look bad at all. So, the bakery was accidentally serving up bad bread to thousands of customers, thinking everything was safe.

The New Experiment: The "Magic Mold Detector"

Researchers in South Africa decided to try something new. They brought in a high-tech Magic Mold Detector (a Point-of-Care test) that could sniff out the invisible mold instantly, right in the bakery, and tell the bakers exactly which ingredient was bad.

They set up a trial called Philani Ndiphile in four local bakeries to see if this new detector could actually work in the real world, not just in a fancy lab.

What They Found: The Good, The Bad, and The "Wait Time"

1. Everyone Wanted the Test (The Good News)
Almost everyone who came to the bakery wanted to use the new detector. 99% of pregnant women agreed to be screened. When the test found the mold, 95% of them got the cure immediately. It was a huge success in terms of people wanting to get checked.

2. The "Lunch Break" Problem (The Bad News)
Here is where things got tricky. The Magic Mold Detector was amazing, but it had a 90-minute wait time.

• Imagine you order a custom cake, and the chef says, "I can make it, but you have to wait 90 minutes in the kitchen while I bake it."
• In the real world, the bakery was very busy. The electricity sometimes flickered (like a power outage in the kitchen). The staff was stretched thin.
• Because of this, only about half of the women got their "cure" (the fix for the mold) on the same day they got the test. The rest had to come back another day.

3. Why Did People Wait?
It wasn't just the machine's fault.

• The Journey: Some women had to walk miles to get to the bakery. If they had to wait 90 minutes, they might miss their bus home or lose a day's wages.
• Hunger: Some women were hungry and couldn't wait around.
• The System: The bakery wasn't built for this new machine. They needed more staff, better electricity, and a way to fit the 90-minute wait into a busy schedule without chaos.

The Big Takeaway

The study proved that the idea works: Pregnant women are eager to get tested, and the new technology finds infections that the old "look-and-smell" method misses.

However, you can't just drop a high-tech machine into an old, crowded kitchen and expect it to run perfectly.

To make this a permanent part of the bakery's routine, they need to:

• Fix the Kitchen: Make sure the electricity is stable and the staff is trained.
• Speed Up the Oven: Find a version of the detector that gives results in 15 minutes, not 90.
• Rethink the Schedule: Integrate the test so it fits naturally into the women's day, rather than making them wait around.

In short: The new tool is a superhero, but it needs a better suit and a faster team to save the day in the real world.

Technical Summary

Technical Summary: Implementation of Point-of-Care STI Screening in South African Antenatal Care

1. Problem Statement

Despite the high prevalence of curable sexually transmitted infections (STIs)—specifically Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis—among pregnant women in South Africa, standard antenatal care (ANC) relies on syndromic management. This approach is clinically inadequate in pregnancy because it fails to detect up to 89% of asymptomatic infections, leading to untreated cases and adverse pregnancy outcomes. While Point-of-Care (POC) screening offers a superior alternative by enabling aetiological diagnosis and same-visit treatment, it has not yet been integrated into national guidelines. There is a critical evidence gap regarding the operational determinants, health system requirements, and contextual barriers necessary to scale POC screening from research settings to routine public healthcare facilities.

2. Methodology

This study employed a mixed-methods process evaluation embedded within the Philani Ndiphile randomized controlled trial (March 2021 – February 2025).

• Setting: Four public clinics in the Eastern Cape province of South Africa.
• Intervention: Implementation of a near-POC, electricity-dependent nucleic acid amplification test (NAAT) with a 90-minute turnaround time for the three target STIs.
• Framework:
  • Quantitative: Evaluated using the RE-AIM framework (Reach, Adoption, Implementation, Maintenance). Metrics included screening uptake, treatment coverage, and follow-up attendance.
  • Qualitative: Included 20 in-depth interviews with pregnant women and five focus group discussions (21 participants) with research staff and government healthcare workers. Analysis was guided by the Consolidated Framework for Implementation Research (CFIR).
• Integration: Findings from both data streams were synthesized using narrative weaving to provide a holistic view of implementation dynamics.

3. Key Contributions

• Operational Evidence: The study moves beyond clinical efficacy to provide granular data on the health system requirements for POC STI screening, specifically highlighting the tension between high diagnostic accuracy and operational constraints (e.g., electricity dependence, turnaround time).
• Contextual Determinants: It identifies that implementation success is not uniform; it varies significantly by facility due to differences in workflow integration, human resources, and infrastructure reliability.
• Socioeconomic Barriers: The research elucidates how external factors—such as transport costs, hunger, and employment conflicts—directly impact patient retention and the ability to receive same-day treatment, factors often overlooked in purely clinical trials.

4. Key Results

• High Uptake and Coverage: Screening uptake was exceptionally high (99.0%). Treatment coverage was also robust, with 95.2% at baseline and 93.5% at repeat screening.
• The "Same-Day" Gap: Despite high treatment coverage, same-day treatment rates were significantly lower (50.7% at baseline and 69.8% at repeat screening). This gap was primarily driven by operational constraints, including the 90-minute assay turnaround time, high patient volumes, and electricity instability.
• Facility Variability: Performance varied substantially across the four clinics, indicating that local context (staffing, workflow, infrastructure) is a decisive factor in implementation success.
• Stakeholder Perspectives:
  • Patients: Valued the screening primarily for the protection of infant health.
  • Providers: Recognized the clinical superiority of POC testing over syndromic management but cited workforce shortages, resource limitations, and maintenance issues as major hurdles.
• Retention Factors: Attendance for follow-up was higher when screening was seamlessly integrated into routine ANC workflows. Conversely, socioeconomic stressors (transport, hunger) hindered retention.

5. Significance and Implications

• Policy Relevance: The study provides critical evidence to inform South African national policy deliberations. It demonstrates that while POC screening is acceptable and feasible in a research context, current operational models are insufficient for routine scale-up.
• Strategic Recommendations: For sustainable integration into national guidelines, the authors argue for:
  1. Workflow Integration: Aligning testing protocols with existing ANC routines to minimize disruption.
  2. Infrastructure Strengthening: Addressing electricity reliability and supply chain stability.
  3. Diagnostic Innovation: Developing or deploying faster diagnostics that do not rely on a 90-minute turnaround to facilitate true same-day treatment.
  4. Context-Adapted Models: Designing delivery models that account for socioeconomic barriers (e.g., transport support) to ensure equitable access.

In conclusion, the Philani Ndiphile process evaluation confirms that POC STI screening is a viable public health intervention but underscores that technical feasibility alone is insufficient. Successful scale-up requires a systemic approach that addresses operational bottlenecks, workforce capacity, and the socioeconomic realities of the patient population.