Evaluation of a multi-level intervention to improve post-partum intrauterine device services in Rwanda

Ethical considerations and consent

The Emory University Institutional Review Board (IRB) and the Rwanda National Ethic Committee (RNEC) approved the research component (focus group discussions and surveys) of the project (IRB 00001497). Written informed consent was obtained from all participants prior to enrollment. The Emory University IRB determined the programmatic service delivery component of the project (PPIUD promotions and insertions provided by government clinic staff) was exempt from review.

Intervention framework

To develop an evidence-based, multi-level intervention to improve PPIUD supply and demand coordination, our innovative strategy combined behavioral science and operations research methods, specifically using a multi-level implementation science framework based on Greenhalgh et al.²⁴ and the Theory of Planned Behavior²⁵. Drawing on input from stakeholders, providers, community health workers, and couple/clients, we designed the intervention to address barriers at multiple-levels. This framework is outlined in Figure 1 and indicates intervention activities designed to change an agent’s attitudes, norms, and perceived control, which in turn affect their intention to either support, provide, promote, or take up a PPIUD. These activities are described in detail below.

Figure 1. Framework of the PPIUD intervention at multiple levels of the healthcare system.

Grey boxes indicate intervention activities designed to change attitudes, norms, and perceived control. PPIUD: post-partum intrauterine device; PPFP: post-partum family planning; FPTWG: Family Planning Technical Working Group; ANC: antenatal care; L&D: labor and delivery; FP: family planning; CHW: community health worker; PBF: performance-based financing; MOH: Ministry of Health.

Early stakeholder involvement

Throughout the intervention we received logistical and technical support from a collaborative group of stakeholders at community, facility, non-governmental, and governmental levels. This included the Rwanda MOH, the District Mayors, the Rwandan Family Planning Technical Working Group, and clinic directors and nurse-administrators at the selected hospitals and health centers.

Health facility selection and needs assessments

In May-June 2017, a PSF nurse counselor (RS) and a study physician (RI) reviewed government monthly reports from Kigali health facilities to select the highest L&D-volume hospitals and health centers. Two hospitals (and their two associated health centers) and two additional health centers were selected. A PSF nurse counselor (RS) and a study physician (RI) then assessed infrastructure, staff trained in long-acting reversible contraception (IUD or implant) insertions, staff in L&D and family planning, and staff interested as potential trainees for PPIUD services in the selected health facility. They reviewed IUD stocks and any procedures supporting PPIUD supply or demand.

PPIUD demand creation development

Through formative work in May-July 2017, PSF staff evaluated knowledge, attitudes, and practices regarding PPIUD services among community health workers (CHW) and providers at two high volume health centers which were not selected for our intervention (unpublished manuscript under review; Da Costa V, Ingabire R, Sinabamenye R, Karita E, Umutoni V, Hoagland A, Allen S, Mork E, Parker R, Mukamuyango J, Haddad L, Nyombayire J, Wall KM. An exploratory analysis of factors associated with interest in postpartum intrauterine device (IUD) uptake among pregnant women and couples in Kigali, Rwanda. Submitted 2018; unpublished manuscript under review; Da Costa V, Ingabire R, Sinabamenye R, Karita E, Umutoni V, Hoagland A, Allen S, Mork E, Parker R, Mukamuyango J, Haddad L, Nyombayire J, Wall KM. Perceptions of the postpartum intrauterine device (PPIUD) and implant among pregnant women and couples in Kigali, Rwanda. Submitted 2018). As Rwanda uses a performance-based financing (PBF) system, we also explored provider knowledge of the current PBF structure and other insurance programs for family planning method provision, and asked whether these influenced the methods they provide. We also evaluated knowledge, attitudes, and practices among pregnant women and couples during early ANC visits (men often attend these visits with their partners). Survey and focus group topics included: demographics; previous pregnancy, birth spacing, and family planning history; postpartum long-acting reversible contraception knowledge, attitudes, and practices; and personal and community perceptions of long-acting reversible contraception. Each survey and focus group discussion took approximately 45 minutes to complete, and each individual study participant was compensated $3.60 United States Dollars (USD). Information gathered from this formative work led to the development of the PPIUD educational and promotional flipchart (Supplementary File 1).

Post-partum IUD service delivery training

In August 2017, health care providers (nurses and midwives working in L&D and family planning) from our selected government health facilities were trained by two national PPIUD trainers located at the selected district hospitals. The training included a 2-day didactic session conducted at PSF (adapted from didactic and practical training materials developed by JHPIEGO and USAID in collaboration with the MOH).

We trained a maximum of 12 trainees per didactic session. The didactic training included information about IUD and PPIUD insertion and removal procedures and follow-up, the use of the PPIUD flipchart in counseling, mock counseling sessions, as well as PPIUD insertion and removal trainings using ‘Mama-U’ (Laerdal Medical) postpartum uterus models. Pre- and post-training tests (adapted from the USAID and Maternal and Child Health Integrated Program Postpartum IUD Training Guide²⁶; Supplementary File 2) consisted of 10 true or false questions and were administered before and after the training.

After passing the didactic training session, two trainees at a time would conduct PPIUD insertions at a selected district hospital under the supervision of a national trainer. The trainees were required to insert correctly and comfortably five PPIUDs under supervision to be PPIUD certified. These five insertions had to include at least one of the following PPIUD insertion timings: immediate post-placental, 10 minutes to 48 hours post-delivery, and 4-6-weeks post-delivery. Checklists for PPIUD insertion practices guided the certification process. Intra-cesarean and post-abortion IUD insertions were provided by previously trained doctors and those certified in PPIUD.

Demand creation

In addition to training PPIUD providers to use the PPIUD promotional flipchart, we trained government clinic staff in family planning, ANC, L&D, and infant vaccination to promote the service at the selected facilities. Trainings were comprised of a 3-hour long didactic session led by PSF staff followed by one supervised promotion session. Additionally, we trained CHWs affiliated with the selected health facilities to use the flipchart to promote post-partum family planning in the community beginning in March 2018. CHWs received a 1-day training on the use of the PPIUD flipchart and couples’ family planning counseling strategies. Women were referred to the facility by their CHW if interested to receive an IUD. Thus, women and couples were provided with PPIUD information at many different time points at the selected health facilities (during ANC, L&D, and infant vaccination up to 6 weeks post-delivery) as well as in the community.

Follow-up procedures

PPIUD follow-up appointments were scheduled 10 days after IUD insertion. Those who had insertions within 48 hours of delivery and who missed their 10-day follow-up visit were assessed at their infant’s first vaccination visit 6 weeks post-partum. Women coming for follow-up appointments were asked if they had complaints, and a pelvic exam for infection and IUD placement was performed. IUD strings were trimmed as needed and a pelvic ultrasound was recommended if the strings were not visible during physical exam. Women whose IUDs expulsed or who requested a removal were offered the family planning method of their choice. To increase follow-up, in March 2018 we began providing CHWs with lists of clients in their catchment areas who were pending follow-up to remind those women about their appointments.

Reimbursements and other compensation

PPIUD trainees were provided with per diem and transport reimbursement for the time spent training ($5.79 USD per day for approximately two weeks of training). All other reimbursements began in March 2018. Reimbursements to the selected facilities for administrative costs associated with implementing the PPIUD program were provided at $57 USD per month. Using the PBF system as a guide²⁷, CHWs were incentivized $0.57 USD per client presenting their referral when requesting a PPIUD and providers were reimbursed $1.20 USD/PPIUD insertion. These payments were made to their facility and included with their regular PBF pay. We began providing transportation reimbursement for women to attend PPIUD follow-up visits ($2.29 USD/client) as follow-up visits were not part of the routine schedule for new mothers.

Data collection

PPIUD service delivery and promotions began in August 2017. A unique code unlinked to patient identifiers allowed tracking of clients from the community and ANC through L&D and infant vaccination. Since promotions occurred in several settings, promotions given by CHW were tracked using referral slips. Promotions in ANC included a group talk followed by one-on-one counseling for those expressing interest in post-partum family planning. Those receiving one-on-one counseling had their method of interest and estimated date of delivery recorded. During insertion, provider perception of ease of insertion, client anxiety during insertion, and client pain during insertion were captured on scales of 1–10. During follow-up, data collected included method expulsion, genital infection, or method failure (i.e., incident pregnancies occurring after insertion), and client satisfaction with the method was captured on a scale of 1–10. Data was recorded in government log books, extracted and cleaned for data entry into tablets weekly by the PSF field team through the mobile data collection platform Survey CTO v2.41 (Dobility, Cambridge, USA), and finally uploaded into a Microsoft Access database.

Analyses

Analyses were performed using SAS version 9.4 (Cary, NC). We tabulated, by facility: number of providers trained and certified; number of promoters trained; number of clients who received a one-on-one promotion from a CHW or in a health facility; total number of PPIUDs inserted (overall and by timing of insertion); and number of follow-up visits. From these data, we calculated the proportion of PPIUD uptake among women who delivered at one of our selected facilities and the proportion of insertions by insertion timing (Table 1). We also plotted PPIUD uptake over time by facility (Figure 2) and by timing of insertion (Figure 3), both after implementation of the intervention and in the six months prior. We then used descriptive statistics to describe insertion and follow-up data (Table 2).

Figure 2. PPIUD insertions over time by facility (N = 2,633 total PPIUD insertions).

Percent increase in monthly insertions comparing February 2017-July 2017 to August 2017-July 2018: 2,749%. PPIUD: post-partum intrauterine device; CHW: community health worker; PBF: performance-based financing; ANC: antenatal care; L&D: labor and delivery; IV: infant vaccination.

Figure 3. PPIUD Insertions over time by insertion timing (N = 2,633 total PPIUD insertions).

PPIUD: post-partum intrauterine device; CHW: community health worker; PBF: performance-based financing; ANC: antenatal care; L&D: labor and delivery; IV: infant vaccination.

Health facility selection and needs assessments

The health facilities selected included Muhima and Kacyiru hospitals (and their associated health centers) and Remera and Kinyinya health centers. The two hospitals, Muhima and Kacyiru, provide routine L&D services for their adjoining health centers and also receive referrals of high-risk and complex obstetric cases from several other health centers. Muhima and Kacyiru health centers provide ANC, family planning, and infant vaccination. The other two health centers, Kinyinya and Remera, were distant from the selected hospitals and from each other, and included routine L&D as well as ANC, family planning, and infant vaccination services. Complex and high-risk obstetric cases from these latter two health centers were referred to nearby hospitals not included in this study. All facilities had infrastructure for IUD insertions and procurement but did not have PPIUD insertion kits or Kelley forceps which were procured.

PPIUD demand creation

Four client focus groups comprised of 32 participants and 14 provider interviews informed the development of surveys which were conducted among 14 health providers, 24 CHWs, and 150 women or couples attending ANC visits. Information gathered from this formative work led to the development of the PPIUD promotional flipchart.

The PPIUD flipchart contained information on the importance of birth spacing, a description of the IUD including efficacy and side effects, and also explained PPIUD insertion timing and expulsion rates. The flipchart included answers to the most frequent client misconceptions about the PPIUD including breastfeeding, heavy bleeding, and its effect on sexual intercourse. Though the focus of the promotional flipchart was on the PPIUD, the promotions included discussion of the other post-partum contraceptive options which are more well-known and widely available²¹. The flipchart was designed to be delivered by clinic providers during ANC, L&D, infant vaccination, or by CHWs in the community to both pregnant women and couples.

Post-partum IUD demand creation and service delivery outcomes

We trained a total of 83 staff to promote PPIUD to couples/clients in-clinic and in the community. 39 providers were trained to deliver the service and 90% of those were certified. Trainees were midwives and nurses working in L&D (85%) or from family planning clinics (15%). All trainees were women.

From August 2017-July 2018, n=9,073 pregnant women were promoted to who later delivered at one of the selected facilities (48% of these expressed interest in PPIUD at the time of promotion). Most promotions took place during L&D (65%) or ANC (20%). Most (95%) of the women only received one promotion, with 4% receiving two promotions (and 1% receiving three to four promotions). Overall, n=2,633 PPUIDs were inserted (29% PPIUD uptake) (Table 1). Timing of promotion was associated with uptake (p<0.05), with highest uptake for promotions delivered during L&D (35%) versus the lowest uptake for promotions delivered during ANC (9%, Dataset 1²⁸). Increasing number of promotions received was not statistically significantly associated with PPIUD uptake, but a trend was observed (p=0.07, Dataset 1²⁸).

PPIUD insertions over time by facility

In the 6-months prior to the intervention (February 2017-July 2017), 46 PPIUDs were inserted in the selected health facilities. The percent increase comparing monthly PPIUD insertions between February 2017-July 2017 to August 2017-July 2018 was 2,749% (Figure 2). We saw an immediate increase in PPIUD uptake as training/promotions began which decreased slightly after initial trainings/supervised certifications ended. Once PBF-incentives began along with training of CHWs to promote PPIUDs in the community, we again observed an increase in insertions. Insertions decreased in June 2018 as seven PPIUD certified nurses began their annual or maternity leave, followed by a subsequent increase as certified providers rearranged their workloads accordingly to compensate.

PPIUD insertions over time by insertion timing

In the initial three months of the program, insertions placed between 10 minutes to 48 hours post-delivery were the most common, but from November 2017 onward post-placental insertions were the most common. Overall, 60% of insertions were immediately post-placental, 17% occurred 10 minutes to 48 hours post-delivery, 8% occurred 4 to 6 weeks post-delivery, 13% occurred intra-cesarean section, and 2% occurred post abortion (Figure 3).

Insertion outcomes among women receiving a PPIUD

Of the 2,633 women receiving PPIUDs, the average age was 28.4 and average parity was 2.4. Provider perception of ease of insertion was high across facilities (average score of 9.2/10), and patient perception of anxiety and pain were low (average scores of 1.8/10 and 1.9/10, respectively) (Table 2). Remera health center had slightly higher than average patient anxiety and pain scores relative to the other facilities.

N=1,418 (60%) women who were due for PPIUD follow-up visits attended them. Overall proportions of expulsions were low at 6% (N=80), and over half (59%) of women who experienced an expulsion had an IUD reinserted. Expulsion proportions were similar for post-placental, 10 minutes to 48 hours post-delivery, intra-caesarian, and 4 to 6 weeks post-delivery insertions, but the small number of post-abortion insertions had a higher expulsion proportion (3/18, 17%, Dataset 1²⁹). Infections were extremely uncommon across all facilities at 0.4%, and no cases of IUD failure were identified. One percent of women requested removals, with the most commonly cited reason for removal being that the husband (30%) or the woman (25%) did not like the method (Dataset 1²⁹). Overall satisfaction with the PPIUD was very high across all facilities (average score of 9.9/10).

Supply

This study demonstrated that it is feasible to train government providers to deliver consistent, quality PPIUD services that are adaptable with their current workload. Staff turnover and leave was a challenge, and new and refresher trainings will be needed over longer timeframes. However, staff began to train each other near the end of the implementation and took over intra-cesarean section insertions from previously trained doctors, indicating the sustainability of our model. PBF-type incentives appeared to support providers and facilities in providing the service (offsetting administrative costs incurred by facilities and time costs to providers). Though we encountered no issues with stockouts, other studies have observed such challenges, and the potential for device stockouts must be monitored.

PPIUD demand creation and uptake

Provider training and infrastructure alone is not sufficient to ensure the success of PPIUD services and increase demand, especially for the less well-known IUD^21,30, and several demand creation strategies may be needed. We observed a significant increase in PPIUD uptake pre- versus post- intervention after PPIUD supply and demand coordination began. Demand was generated by both in-clinic promotions as well as by CHWs affiliated with facilities. In future studies, we will expand CHW promotions and conduct comparative effectiveness studies of these two promotional strategies. A study in Nigeria showed that repeated post-partum family planning promotions over multiple ANC sessions increased post-partum family planning use³¹, as we similarly observed a trend for the effect of multiple promotions.

PPIUD insertion timing

Most PPIUD insertions were post-placental (60%) and the second most frequent timing of insertion was 10 minutes to 48 hours after delivery indicating that our promotions often lead to insertion before women leave the facility after delivery. In a study that integrated PPIUD services into maternal care facilities in six low- and middle-income countries, researchers found that in Rwanda, 27% of PPIUD insertions were post-placental, 43% were intra-cesarean, and 30% were within 10 minutes to 48 hours of delivery; in this study, insertion timings varied widely by country with Rwanda having the lowest proportion of insertions being post-placental¹⁰. In a study in providing post-partum family planning services in West and Central Africa, most PPIUD insertions were intra-cesarean (33%) with relatively fewer being post-placental (20%). The authors suggest this may be due to weak post-partum family planning counseling in ANC clinics³².

PPIUD follow-ups

PPIUD follow-up proportions may be affected by women attending other nearby health centers not included in this study for follow-up, or simply not attending follow-up visits. Similarly, in a study in providing post-partum family planning services in West and Central Africa, 42% of women who had a PPIUD inserted also attended follow-up (13.8% in person at the clinic between 2–6 weeks, and 28.6% by phone at 6 weeks)³².

Of those with PPIUD follow-up appointments, reported satisfaction with the method was high, and we observed very few adverse outcomes during the study. PPIUD expulsions were relatively rare (6%) and were highest for post-abortion insertions. Infections and removals were also rare (<=1% of insertions) and no failures were observed. Similarly, in a study that integrated PPIUD services into maternal care facilities in low- and middle-income countries, expulsion rates were low (ranging from 2–4%), infection rates were low (0–1%), and removals ranged from 1%–11%¹⁰. In a study in providing post-partum family planning services in West and Central Africa, 0.8% of PPIUD users self-reported expulsions and only 0.5% (n=12) requested removal (10 desired pregnancy and two had husbands who disapproved of the PPIUD)³². These and our data are reassuring regarding PPIUD insertions and adverse events.

Given that the majority of the removals in our study were due to male partner’s not liking the method, male involvement during promotions may be important. A review of 26 post-partum family planning studies in low- and middle-income countries found that male partner involvement may increase knowledge and use of postpartum contraception³³, and other studies found male partner involvement is important for postpartum contraception uptake and continued use^28,34–36. We are currently conducting focus groups and surveys to further explore the role of male involvement in post-partum family planning choices.

PBF-type incentives

PBF-type incentives appeared to increase the uptake of PPIUDs in our study. Under the current Rwandan PBF structure, providers receive a flat rate for all family planning methods provided to a new user. Thus, the IUD which takes considerably more time and skill to provide is reimbursed at the same rate as methods that are easier to administer such as OCPs and injectables. This could create a disincentive to providing IUDs. We are currently exploring stakeholder and policymaker perceptions related to restructuring the PBF reimbursements for family planning methods based on the skill and time it takes to provide them.

Limitations

Several limitations warrant discussion. Group promotions were often conducted in ANC, L&D, and infant vaccination and time constraints limited the number of women who could receive a subsequent one-on-one counseling session to those who were interested in post-partum family planning. As a result, more women heard about the PPIUD than were recorded. The two hospitals had large volume L&D services that included referrals of high-risk and complex cases from non-participating clinics. If those PPIUD clients did not return to one of our selected health facilities for follow-up assessment, they would not be captured. Because we were collecting service delivery data, we do not have extensive demographic information to explore demographic factors associated with uptake. Similarly, we did not collect data on why women selected or did not select the PPIUD. We are currently conducting surveys with women who received our post-partum family planning promotions to explore these reasons. Finally, given the pre-post study design, it is not possible to rule out the effect of secular changes on PPIUD uptake, though no national interventions or other similar projects were taking place in the capital during our implementation.