Effect of pregnancy test kits on family planning clients supplied by community health workers
Last registered on October 28, 2014

Pre-Trial

Trial Information
General Information
Title
Effect of pregnancy test kits on family planning clients supplied by community health workers
RCT ID
AEARCTR-0000533
Initial registration date
October 24, 2014
Last updated
October 28, 2014 3:38 PM EDT
Location(s)
Primary Investigator
Affiliation
University of California San Francisco
Other Primary Investigator(s)
PI Affiliation
Abt Associates
PI Affiliation
Abt Associates
Additional Trial Information
Status
Completed
Start date
2013-03-01
End date
2014-07-01
Secondary IDs
Abstract
Many countries in sub-Saharan Africa use community health workers (CHWs) to increase access to contraceptives. Before they can provide hormonal contraceptives to clients, CHWs use a pregnancy checklist, a series of questions that allows CHWs to assess whether a woman is pregnant. However, CHWs may not trust the checklist and it categorizes many non-pregnant women as pregnant. This study assesses the impact of offering free pregnancy test kits to CHWs on the number of clients that they supply hormonal contraceptives to. Using a randomized-controlled design, we randomly assigned CHWs in three regions in Madagascar to either receive pregnancy tests kits (treatment) or not (control). This intervention increased the number of new hormonal contraceptive clients per CHW by 0.6 clients per month, representing a 23% increase. This intervention provides evidence that offering pregnancy test kits is a promising approach to increase adoption of hormonal contraceptives.
External Link(s)
Registration Citation
Citation
Chankova, Slavea, Alison Comfort and Randall Juras. 2014. "Effect of pregnancy test kits on family planning clients supplied by community health workers." AEA RCT Registry. October 28. https://www.socialscienceregistry.org/trials/533/history/3000
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Experimental Details
Interventions
Intervention(s)
The intervention involves offering free pregnancy test kits to CHWs for distribution to their clients, along with training on how to use these tests.
Intervention Start Date
2013-04-01
Intervention End Date
2013-12-01
Primary Outcomes
Primary Outcomes (end points)
The primary outcome of interest is the monthly number of new hormonal contraceptive clients to whom CHWs distribute contraceptives. We also separate this result into the number of new oral contraceptive clients and new injectable clients, which together make up the total number of new hormonal contraceptive clients. New hormonal contraceptive clients are hormonal contraceptive clients who either: (1) have never previously obtained contraceptives from the CHW; or (2) had previously obtained hormonal contraceptives from the CHW but had stopped for a period, and have now obtained a new prescription.

The three secondary outcomes of interest include the monthly number of family planning sessions, the monthly number of times the pregnancy checklist was used, and (for treatment group CHWs only) the monthly number of pregnancy test kits distributed.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The study uses a randomized-controlled trial (RCT) design in which CHWs were either offered free pregnancy test kits to distribute as well as training on how to use them (the treatment group) or were offered neither the tests nor the test-specific training (the control group).
Experimental Design Details
The study uses a randomized-controlled trial (RCT) design in which CHWs were either offered free pregnancy test kits to distribute as well as training on how to use them (the treatment group) or were offered neither the tests nor the test-specific training (the control group). In each study region, half of the eligible CHWs were randomly assigned, at the individual level, to the treatment group and half to the control group. Treatment and control group CHWs were then invited to participate in separate training sessions on completing the monitoring forms for the outcome data. Only the treatment group received the additional training on pregnancy test kits. At this training, treatment group CHWs received 50 pregnancy test kits that they could begin distributing for free in their communities.
Randomization Method
The randomization was done in the office by a computer. The CHWs were stratified by region. Using a random number generator, they were then listed in increasing order. The first half of the CHWs were selected into the treatment group.
Randomization Unit
Randomization was conducted at the individual level.
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
622 community health workers

The study was implemented in three regions of Eastern Madagascar – Aloatra Mangoro, Atsinanana, and Analanjirofo. Study participants were CHWs supported by USAID’s Santenet2 project, implemented from 2008 to 2013. All CHWs in the sample had been trained to provide injectable contraceptives in addition to oral contraceptives as part of the Santenet2 project. Out of the 1,056 CHWs trained in injectables in the three study regions, 350 (33%) were excluded from the sample because they were no longer working as a CHW. We then excluded the top 5% of CHWs measured by number of FP clients. We expect this to increase statistical power by reducing outcome variance attributable to outliers. Two hard-to-reach districts were also excluded for practical reasons. The final experimental sample consisted of 622 CHWs.
Sample size: planned number of observations
622 community health workers
Sample size (or number of clusters) by treatment arms
311 community health workers in control group, 311 community health workers in treatment group (offered free pregnancy tests)
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
The Minimum Detectable Effect Size for the number of new hormonal contraceptive clients (main outcome) is 0.19 standard deviations based on alpha=0.05 and power=80%.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Abt Associates Institutional Review Board
IRB Approval Date
2012-10-05
IRB Approval Number
0622
IRB Name
Ministere de la Sante Publique-Comite d'Ethique Madagascar
IRB Approval Date
2013-01-16
IRB Approval Number
007
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
Yes
Intervention Completion Date
December 01, 2013, 12:00 AM +00:00
Is data collection complete?
Yes
Data Collection Completion Date
December 01, 2013, 12:00 AM +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
535 community health workers
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
1,554 observations (multiple observations per CHW)
Final Sample Size (or Number of Clusters) by Treatment Arms
272 community health workers in treatment group, 263 community health workers in control group
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers