Figure 1 is a map of the Southwest Trifinio communities included in the trial, and Table 1 illustrates how the communities were clustered and randomized by nurse team. Figure 2 presents the participant flow through the trial. There were no eligibility criteria for communities and all community leaders agreed to support participation in the study with none excluded. Using previously described methods these communities were matched on expected births, by nursing teams, into eight clusters that were then randomized in order that each nurse team had at least one intervention and control group. Four clusters were randomized to intervention, four to control. All intervention clusters received the intervention with no control clusters receiving the intervention, as planned. Enrollment began October 10, 2018 and ceased September 24, 2019. The mean size of intervention clusters was 25 women with a 4.7 standard deviation. The mean cluster size of control clusters was 27 women with a 15.4 standard deviation. Of the 141 women approached to participate in the study in the intervention clusters, 26 were not eligible and 7 declined to participate. Of 108 women who received the intervention, 3-month outcome data was available for 101 of them. In the control clusters, of 143 women approached for study participation 24 were not eligible and 19 declined to consent. Of the 100 women who were enrolled, none were lost to follow-up by 3 months.
Table 1. Cluster Randomization by Nurse Team
Table 2 describes the overall study population and the subpopulations of women by intervention arm. Women were young, with a median age around 22 years old, the majority had had some education (around 90%), and most were married (around 88%). The largest subpopulation of the cohort was primiparous (around 39%) and the majority had received greater than four prenatal visits (about 81%) through the Madres Sanas program. About two-thirds of women experienced vaginal birth and were delivered by a nurse or physician, about half delivered in a facility, and around three-fourths gave birth to infant weighing at least 2500 grams. The majority of babies were born alive and remained alive by the 72-hour postpartum visit (around 93%), most were alive at the 40-day enrollment visit (about 95%), around 7% of women were already sexually active by the time of enrollment, and over one-third of women did not desire future fertility (about 37%). Randomization was effective and study arms were not statistically different by any of these characteristics when checked (p-values not shown).
Table 2. Characteristics of Study Population by Cluster
|
Total Population
(n = 208)
|
Control Clusters (4)
(n = 100, 48.1%)
|
Intervention Clusters (4)
(n = 108, 51.9%)
|
Sociodemographic Characteristics
|
Age in years (median IQR)
Missing
|
21.8 [18.7,25.4]
3 (1.4%)
|
21.9 [18.8,25.4]
1 (1.0%)
|
21.8 [18.7,25.5]
2 (1.9%)
|
Education
None
Any
Missing
|
17 (8.2%)
188 (90.4%)
3 (1.4%)
|
8 (8.0%)
91 (91.0%)
1 (1.0%)
|
9 (8.3%)
97 (89.8%)
2 (1.9%)
|
Married
Yes
No
Missing
|
183 (88.0%)
23 (11.1%)
2 (0.9%)
|
88 (88.0%)
12 (12.0%)
0 (0.0%)
|
95 (87.9%)
11 (10.2%)
2 (1.9%)
|
Obstetric and Antepartum Characteristics
|
Parity
1
2
3
4+
Missing
|
81 (38.9%)
59 (28.3%)
33 (15.9%)
33 (15.9%)
2 (1.0%)
|
39 (39.0%)
31 (31.0%)
15 (15.0%)
15 (15.0%)
0 (0.0%)
|
42 (38.8%)
28 (25.9%)
18 (16.7%)
18 (16.7%)
2 (1.9%)
|
Number of Madres Sanas Prenatal Visits
< 4
4+
Missing
|
28 (13.4%)
169 (81.3%)
11 (5.3%)
|
13 (13.0%)
82 (82.0%)
5 (5.0%)
|
15 (13.9%)
87 (80.6%)
6 (5.5%)
|
Delivery Characteristics
|
Mode of Delivery
Vaginal Birth
Cesarean Birth
Missing
|
127 (61.0%)
69 (33.2%)
12 (5.8%)
|
63 (63.0%)
31 (31.0%)
6 (6.0%)
|
64 (59.3%)
38 (35.2%)
6 (5.5%)
|
Location of Delivery
Home, Private Clinic, or Other
Facility (Hospital)
Missing
|
91 (43.7%)
106 (51.0%)
11 (5.3%)
|
42 (42.0%)
53 (53.0%)
5 (5.0%)
|
49 (45.4%)
53 (49.1%)
6 (5.5%)
|
Birth Attendant
Comadrona (TBA, “unskilled”)
Nurse or Physician (“skilled”)
Missing or “I don’t know”
|
61 (29.3%)
135 (64.9%)
12 (5.8%)
|
29 (29.0%)
64 (64.0%)
7 (7.0%)
|
32 (29.6%)
71 (65.7%)
5 (4.6%)
|
Birthweight at Delivery
2500g
2500g+
Missing
|
28 (13.5%)
161 (77.4%)
19 (9.1%)
|
10 (10.0%)
81 (81.0%)
9 (9.0%)
|
18 (16.7%)
80 (74.0%)
10 (9.3%)
|
Postpartum Characteristics
|
Sex of Infant
Male
Female
Missing
|
92 (44.2%)
101 (48.6%)
15 (7.2%)
|
40 (40.0%)
53 (53.0%)
7 (7.0%)
|
52 (48.2%)
48 (44.4%)
8 (7.4%)
|
Infant Outcome
Macerated Stillbirth
Fresh Stillbirth
Born Alive, died before 72-hour visit
Born Alive, alive at 72-hour visit
Missing
|
0 (0.0%)
2 (1.0%)
2 (1.0%)
194 (93.3%)
10 (4.7%)
|
0 (0.0%)
1 (1.0%)
0 (0.0%)
94 (94.0%)
5 (5.0%)
|
0 (0.0%)
1 (0.9%)
2 (1.8%)
100 (92.6%)
5 (4.7%)
|
Infant Status at 40 days Postpartum
Alive
Dead
Missing
|
197 (94.7%)
2 (1.0%)
9 (4.3%)
|
95 (95.0%)
1 (1.0%)
4 (4.0%)
|
102 (94.4%)
1 (0.9%)
5 (4.7%)
|
Sexual Activity Since Birth
Yes
No
Missing
|
16 (7.7%)
181 (87.05%)
11 (5.3%)
|
6 (6.0%)
91 (91.0%)
3 (3.0%)
|
10 (9.3%)
90 (83.3%)
8 (7.4%)
|
Desired Timeframe Until Next Pregnancy
Approximately 2 years
Approximately 3 years
> 3 years
I don’t know
No more children desired
Missing
|
1 (0.5%)
8 (3.8%)
71 (34.1%)
44 (21.2%)
77 (37.0%)
7 (3.4%)
|
0 (0.0%)
4 (4.0%)
30 (30.0%)
21 (21.0%)
42 (42.0%)
3 (3.0%)
|
1 (0.9%)
4 (3.7%)
41 (38.0%)
23 (21.3%)
35 (32.4%)
4 (3.7%)
|
Note: no bivariate comparisons using a generalized liner model mixed effects regression adjusted for cluster were significant, pvalues not shown
Table 3 presents the primary outcome of the paper, which was comparing implant uptake at 3 months by study arm. First, however, it illustrates overall contraceptive use by 3 months and how that varies by study arm. In control clusters 56.0% of women were using a method compared to 76.8% of women in intervention clusters, p < 0.001, RR 1.3 [1.1,1.5]. It then shows how that usage breaks down by method of contraception including modern and traditional methods. Before this current study regarding implant usage, we observed high usage of short-acting methods, which included condoms, pills, and the injection. The use of these methods did not vary by study arm with respect to use by three months (although 94.6% of women in control clusters opting for these methods compared to 61.4% of women in intervention clusters), p = 0.72, RR 0.98 [0.8,1.1]. Finally, for our primary outcome, implant usage by 3 months was statistically significantly different between study arms with 2 women from control clusters using the method compared to 28 women in the intervention arm, p < 0.001, RR 1.3 [1.2,1.4]. Of note, no adverse outcomes or pregnancies have been reported to date (data not shown).
Table 3. Implant Utilization by Three Months (Primary Outcome) and Overall Contraceptive Use by Three Months (Secondary Outcome)
|
Total Population of Women who Initiated a Method by 3 Months
(n = 208)
|
Control Clusters (4) Women who Initiated a Method by 3 Months
(n = 100, 48.1%)
|
Intervention Clusters (4)
Women who Initiated a Method by 3 Months
(n = 108, 51.9%)
|
P-Value
|
RR
[95% CI]
|
Using a Method by 3 Months
Yes (% of total)
|
139 (66.8%)
|
56 (56.0%)
|
83 (76.8%)
|
<0.001
|
1.3
[1.1, 1.5]
|
Method Being Used at 3 Months
No Method
Abstinence
Natural Family Planning
Lactational Amenorrhea
Condoms
Pills
Injection
Implant
Intrauterine Device
Female Sterilization
Male Sterilization
Missing
|
62 (29.8%)
0 (0.0%)
4 (1.9%)
0 (0.0%)
1 (0.5%)
4 (1.9%)
99 (47.6%)
30 (14.4%)
0 (0.0%)
1 (0.5%)
0 (0.0%)
7 (3.4%)
|
44 (44.0%)
0 (0.0%)
1 (1.0%)
0 (0.0%)
0 (0.0%)
0 (0.0%)
53 (53.0%)
2 (2.0%)
0 (0.0%)
0 (0.0%)
0 (0.0%)
0 (0.0%)
|
18 (16.7%)
0 (0.0%)
3 (2.8%)
0 (0.0%)
1 (0.9%)
4 (3.7%)
46 (42.6%)
28 (25.9%)
0 (0.0%)
1 (0.9%)
0 (0.0%)
7 (6.5%)
|
<0.001
|
5.6
[2.6,12.0]
|
Using a Short-Acting Method at 3 Months
Yes (% of users)
|
104 (74.8%)
|
53 (94.6%)
|
51 (61.4%)
|
0.72
|
0.98
[0.8,1.1]
|
Using the Implant at 3 Months
Yes (% of users)
|
30 (21.6%)
|
2 (3.6%)
|
28 (33.7%)
|
<0.001
|
1.3
[1.2,1.4]
|
Note: p-values the result of a generalized linear model mixed effects regression adjusted for cluster
*: Short Acting Method Includes: condoms, pills, injection
Figure 3 visually illustrates the contraceptive choices of women in the intervention arm of the trial who were offered free contraceptives in their homes at the time of their 40-day postpartum visit as well as the method they were using by 3 months post-enrollment. Seventy-four of the 108 women (68.5%) in the intervention clusters initiated a contraceptive method at enrollment; 2 opted for condoms (1.9%), 5 for pills (4.6%), 37 for the injection (34.3%), and 30 for the implant (27.8%). The remaining 34 women (31.5%) declined to initiate a method with no missing data at that timepoint. By the 3-month post-enrollment timepoint, the continuation rates of these methods were 50%, 80%, 76%, and 90%, respectively. In the intervention population, by 3 months, 18 women were still not using a method (16.7%) and 7 (6.5%) had been lost to follow-up. Of those that had initiated, continued, or started a second method, 3 women (2.8%) were using natural family planning, 1 (0.9%) condoms, 4 pills (3.7%), 46 (42.6%) the injection, 28 (25.9%) the implant, and 1 (0.9%) sought female sterilization.
Table 3 presents secondary outcomes collected at 3 months in the intervention arm. Of women still on their initial method of choice, 90% were very satisfied. Of those who discontinued (n = 11), 3 discontinued due to side effects, 2 due to partner preference, 1 did not know why she discontinued, 2 did not want to contracept anymore, 1 sought sterilization, and 1 forgot to take her pills. Of the women who discontinued and did not initiate another method (n = 4), each one had a different reason, including: partner preference, could not continue due to resource constraints, did not know, and did not want to contracept anymore. In the population of women who originally declined a method at the 40 day visit (n = 34), 19 subsequently initiated a method by seeking it in the community, and 100% of them reported they were very satisfied on that method. Of the remaining 15 women still using no method by 3 months (44% of those who originally declined), 13 reported a reason for not initiating a method, which included: not having a partner or due to partner preference, not knowing, unable to obtain a method because the health post was closed, declining to start because menses had not resumed, not wanting to use a method, and not wanting to “ruin” her uterus.
Figure 4 and Table 4 illustrate the experience of women in the control clusters. Of the 100 women followed through 3 months, with no lost to follow-up, 44 (44%) had not initiated a method. Reasons these women cited for not choosing a method were: not having a partner or due to partner preference, could not continue due to resource constraints, did not know, did not want to, wanted to menstruate first, wanted to wait until the baby was older, was already using or wanted another method (natural family planning, intrauterine device, sterilization), and forgot or was afraid to start a method. In the remaining 56 women who chose to start a contraceptive by 3 months, 53 sought the injection, 1 used natural family planning, and 1 woman obtained the implant. These 56 women were largely very satisfied or a little satisfied with the method they chose (n = 53), with 2 women reporting a little dissatisfaction and 1 woman reporting she was very dissatisfied.
Table 4. INTERVENTION ARM, Three Month Secondary Outcomes
Satisfaction of women still on method at 3 months (n = 60)
|
Satisfaction Level on Method
|
Very Satisfied
|
54
|
90.0%
|
A Little Satisfied
|
0
|
0.0%
|
A Little Dissatisfied
|
5
|
8.3%
|
Very Dissatisfied
|
1
|
1.7%
|
Missing
|
0
|
0.0%
|
Reasons women discontinued initial method (n = 11)
|
Reason for Initial Method Discontinuation
|
Did not Like Side Effects
|
3
|
27.2%
|
Partner Not Permitting Contraceptive Use
|
2
|
18.2%
|
Did not Know
|
1
|
9.1%
|
Other:
- Did not want to contracept anymore (2)
- Sterilization
- Forgot to take pills
|
4
|
36.4%
|
Missing
|
1
|
9.1%
|
Reason for Not Starting Another Method (n = 4)
|
Partner Not Permitting Contraceptive Use
|
1
|
25.0%
|
Doesn’t Want to Start Because Can’t Continue Due to Cost, Time, Transport
|
1
|
25.0%
|
Doesn’t Know
|
1
|
25.0%
|
Other:
Did not want to contracept anymore
|
1
|
25.0%
|
Satisfaction among women who started a method after originally declining, and
Reasons women cited for not initiating a method among those who did not start a method by three months
|
Satisfaction Level on Method
(N = 19)
|
Very Satisfied
|
19
|
100.0%
|
A Little Satisfied
|
0
|
0.0%
|
A Little Dissatisfied
|
0
|
0.0%
|
Very Dissatisfied
|
0
|
0.0%
|
Missing
|
0
|
0.0%
|
Reason for Not Choosing a Method
(N = 15)
|
No Partner
|
7
|
46.6%
|
Partner Not Permitting Contraceptive Use
|
1
|
6.7%
|
Doesn’t Know
|
1
|
6.7%
|
Other:
- Health post was closed
- Has not menstruated yet
- Does not want to use a method
- Does not want to “ruin” uterus
|
4
|
26.7%
|
Missing
|
2
|
13.3%
|