An Impact Evaluation of the Introduction of a New Woman’s Condom on Overall Condom Use in Urban Lusaka, Zambia
Last registered on April 18, 2017

Pre-Trial

Trial Information
General Information
Title
An Impact Evaluation of the Introduction of a New Woman’s Condom on Overall Condom Use in Urban Lusaka, Zambia
RCT ID
AEARCTR-0000899
Initial registration date
October 26, 2015
Last updated
April 18, 2017 8:40 AM EDT
Location(s)

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Primary Investigator
Affiliation
Innovations for Poverty Action
Other Primary Investigator(s)
PI Affiliation
Innovations for Poverty Action
PI Affiliation
Innovations for Poverty Action
Additional Trial Information
Status
On going
Start date
2015-10-26
End date
2017-08-31
Secondary IDs
Abstract
A third generation, premium female condom called the Maximum Diva Woman’s condom will be marketed in Lusaka, Zambia in November 2015. The Maximum Diva Woman’s Condom is a new type of female condom that provides non-hormonal protection against unintended pregnancy and sexually transmitted infections. With the introduction of this new product, the question arises regarding whether the availability and promotion of the Maximum Diva Woman’s Condom will increase overall condom use. This study will evaluate the effect of introducing a new female condom to the Zambian market, a mass media campaign, and interpersonal communication intervention on the prevalence of female condom use and prevalence of overall condom use.

Specifically, the study will examine the effect of these two approaches on female and male condom use. We also will look at willingness to use, knowledge, attitudes and practice regarding female condoms. To understand the effect of interpersonal communication, the proposed study will gather information on communication with sexual partners.
External Link(s)
Registration Citation
Citation
Chowdhuri, Rachna, Thoai Ngo and Jessie Pinchoff. 2017. "An Impact Evaluation of the Introduction of a New Woman’s Condom on Overall Condom Use in Urban Lusaka, Zambia." AEA RCT Registry. April 18. https://www.socialscienceregistry.org/trials/899/history/16654
Experimental Details
Interventions
Intervention(s)
The major components that will be evaluated include:

1. Distribution of the MDWC: The MDWC will be distributed to pharmacies and other outlets by SFH located in the geographic areas where the study will be implemented. The distribution of the MDWC will take place across both study arms. Information regarding where the MDWC is stocked and how often it is available will be collected throughout the study to determine availability of the product and whether that varies across wards.

2. Mass Media: The MDWC will be advertised widely, targeting young adults through radio, billboards, news media, social media, and a mobile website. This mass media platform will be implemented across both study arms. The mobile website will be branded under “Smart Sex”, and will disseminate information about family planning and serve as an interactive forum for young men and women to ask sexual health related questions and generally discuss SRH related topics. SMS blasts and social media messaging will be used to direct individuals to the website. There will also be a “Brand Ambassador” who will serve as a spokesperson for the website and for the MDWC. The website will serve as the main venue for the introduction and promotion of the MDWC. Mass media will be targeted to young, urban adults (ages 18 to 24 years) of both genders.

3. Inter-Personal Communication (IPC): IPC agents will be recruited from IPC points within the intervention arm and they will be trained by SFH on communication skills, sexual and reproductive health, technical specifications and use of the Maximum Diva Woman’s Condom, and condom negotiation skills. IPC agents will set up an IPC point in a high traffic area(s) of each ward selected for the intervention arm for initial demand creation, and use their existing and new contacts to access networks of young people in the area for smaller group and on-on-one information sessions. The IPC intervention will be comprised of communication messages focused on how to use and the benefits of the use of MDWCs and MCs for the prevention of unplanned pregnancies. IPC activities will be targeted to both young men and women (aged 18-24 years). The IPC agents will also will be young (18 to 35 years of age) males and females. The key components of the IPC intervention include: 1) Targeting men and women aged 18-24 years; 2) Providing content on the importance of contraceptive use with a focus on the benefits of FCs; 3) Demonstrating how to use the MDWC on a pelvic model; and 4) Training condom use negotiations with a sex partner through theater or role playing. Information will also be distributed in the form of pamphlets.
Intervention Start Date
2015-11-16
Intervention End Date
2016-05-16
Outcomes
Outcomes (end points)
The overall aim of this randomized controlled trial (RCT) is to evaluate how the introduction of the MDWC impacts the condom market in Zambia. Specifically, we will also evaluate the effectiveness of IPC + mass media + distribution of MDWC (intervention) compared to mass media + distribution of MDWC (control) on the prevalence of FC (and specifically MDWC) use and prevalence of overall condom use. The primary specific objectives of this evaluation are: 1) To assess the effect of the introduction of the MDWC on the overall condom market (self-reported condom use and self-reported use of FC2 and MDWC). 2) To determine the additional effect of an IPC intervention on self-reported use of FC (and specifically, MDWC) as compared with just mass media including a website (controlling for any differences between the intervention and control group). 3) To determine the additional effect of an IPC intervention on self-reported use of any condom as compared with just mass media including a website (controlling for any differences between the intervention and control group). 4) To determine the additional effect of an IPC intervention on willingness to use FC (and specifically, MDWC) as compared with just mass media including a website (controlling for any differences between the intervention and control group). The secondary specific objectives of this evaluation are: 5) To determine the effect of an IPC intervention on self-reported knowledge, attitudes and practices regarding the FC, specifically the MDWC, as compared with just mass media including a website (controlling for any differences between the intervention and control group). 6) To determine the effect of an IPC intervention on community level acceptability of FC, specifically the MDWC, compared with just mass media including a website (controlling for any differences between the intervention and control group). 7) To determine the effect of an IPC intervention on self-reported changes in interpersonal communication with sexual partners regarding contraceptive use as compared with just mass media including a website (controlling for any differences between the intervention and control group). 8) To assess women’s and men’s preference for condom brands and specifically the MDWC.
Outcomes (explanation)
Experimental Design
Experimental Design
Forty wards (N=40) in Lusaka and nearby districts will be randomized to the control (n=20 wards) or intervention group (n=20 wards).
Experimental Design Details
Not available
Randomization Method
Randomization done by computer after baseline data collection.
Randomization Unit
Randomization unit is the ward.
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
We will use a sample size of 1,157 individuals per cluster (total of 2,314 individuals). This yields a total of 58 individuals to be interviewed per ward, in a total of 40 wards.
Sample size: planned number of observations
2,314 individuals
Sample size (or number of clusters) by treatment arms
1,157 individuals in control and treatment each
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Innovations for Poverty Action Institutional Review Board
IRB Approval Date
2015-08-11
IRB Approval Number
10854
IRB Name
ERES Converge Institutional Review Board
IRB Approval Date
2015-08-19
IRB Approval Number
2015-Aug-001