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General

Study Overview

Title:

Innovative demand creation for voluntary medical male circumcision for a high impact male population: A pilot study at three high volume clinics in Kampala, Uganda.

Study is 3ie funded:

No

Study ID:

RIDIE-STUDY-ID-533d871d17887

Initial Registration Date:

04/03/2014

Last Update Date:

03/31/2014

Study Status:

In Development

Location(s):

Uganda

Abstract:

Landmark clinical-trials clearly demonstrated circumcision to be an effective and safe method of reducing HIV infection among men in sub-Saharan Africa. Presently only 27 % of Ugandan men between the ages of 15 and 49 years are circumcised yet in a region with high HIV sero-prevalence. Despite numerous attempts to increase uptake of voluntary medical male circumcision (VMMC) among uncircumcised males within Uganda, acceptance is dwindling. We evaluate a pilot VMMC intervention at three urban health centers in Kampala. The intervention targets a potentially high-impact male population consisting of the male partners to pregnant women in the third trimester of pregnancy, and relies on the pregnant mothers as change agents. Among a population of pregnant women in their third trimester attending antenatal care (ANC) in 3 high volume Kampala City Council Authority clinics (KCCA) in Kiswa, Kisenyi and Kawaala, we shall use a quasi-experimental design to evaluate whether pregnant mothers equipped with a theory informed behavior change intervention during ANC visits will encourage intimate partners seek for VMMC.

Registration Citation:

Kambugu, A. and Muganzi, A., 2014. Innovative demand creation for voluntary medical male circumcision for a high impact male population: A pilot study at three high volume clinics in Kampala, Uganda. Registry for International Development for Impact Evaluations (RIDIE). Available at: 10.23846/ridie025

Categories:

Health, Nutrition, and Population
Other

Additional Keywords:

voluntary medical male circumcision, pregnant women, HIV, increase demand, Kampala, Uganda,

Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:

Andrew Kambugu

Affiliation:

Infectious Diseases Institute , College Health Sciences Makerere University, Kampala Uganda

Name of Second PI:

Alex Muganzi

Affiliation:

Infectious Diseases Institute , College Health Sciences Makerere University, Kampala Uganda

Study Sponsor

Name:

International Initiative for Impact Evaluation (3ie).

Study Sponsor Location:

United States

Research Partner

Name of Partner Institution:

Type of Organization:

Location:

Intervention

Intervention Overview

Intervention:

Objectives: 1. To compare demand for VMMC before and after the intervention among uncircumcised male intimate partners to pregnant women in their third trimester. 2. Evaluate the reasons for the observed response to the intervention. Among a population of pregnant women in their third trimester attending antenatal care (ANC) in three high volume Kampala City Council Authority clinics (KCCA) in Kiswa, Kisenyi and Kawaala we shall use a pre-post, quasi- experimental design to deliver a theory informed behavior change intervention in a three-phased implementation process. Over a period of one year from February 2014 we shall use; i) Control phase (three months) to deliver the circumcision information by health care workers to the women attending ANC as per the national policy and standard practice, ii) a “wash out” period (Two months) to prevent contamination, iii) Intervention phase (three months) where an enhanced behavioral change communication (BCC) package based on the information motivation behavior (IMB) model shall be delivered.

Theory of Change:

Multiple Treatment Arms Evaluated?

No

Implementing Agency

Name of Organization:

Infectious Diseases Institute, College of Health Sciences Makerere University, Kampala Uganda.

Type of Organization:

NGO (local)/Community Based Organization/Other civil society organization

Program Funder

Name of Organization:

Centers for Disease Control, USA.

Type of Organization:

Public Sector, e.g. Government Agency or Ministry

Intervention Timing

Intervention or Program Started at time of Registration?

No

Start Date:

07/01/2014

End Date:

10/31/2014

Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:

Other (specify)

Other (not Listed) Method:

Pre-post (Before-after) evaluation

Additional Evaluation Method (If Any):

Other (not Listed) Method:

Method Details

Details of Evaluation Approach:

We shall evaluate impact of the intervention using both quantitative and qualitative measures (mixed method) approaches. Quantitatively for the major endpoint, we shall compare the proportions of men seeking VMMC in the control phase to that from the intervention phase. We shall evaluate the process determining how many women understood the message, were able to deliver it and how many men received the message from partners. Qualitatively by way of in-depth interviews we shall evaluate reasons for the variability in the process.

Outcomes (Endpoints):

Main end point will be the difference in the number of men seeking VMMC in the control phase compared to the intervention phase. We shall also consider secondary outcomes like the number of women who understood the message, the number of women who were able to communicate the message to their spouses and the number of men who accepted the message in both phases of the study.

Unit of Analysis:

Intimate male partners of women attending ANC

Hypotheses:

Unit of Intervention or Assignment:

Pregnant women in third trimester attending ANC

Number of Clusters in Sample:

3 clusters each with 100 participants for the control phase and 3 clusters each with 100 participants for the intervention phase

Number of Individuals in Sample:

600

Size of Treatment, Control, or Comparison Subsamples:

300 in both phases

Supplementary Files

Analysis Plan:

Other Documents:

Data

Outcomes Data

Description:

We shall link the women to their intimate partners using vouchers that are returned during VMMC. Using surveys, we shall evaluate how many pregnant women who received the VMMC intervention; 1. understood the message and 2. delivered it to their spouses. Using in-depth interviews we shall also evaluate why some men didn't return despite receiving the intervention from their spouses.

Data Already Collected?

No

Data Previously Used?

Data Access:

Data Obtained by the Study Researchers?

Data Approval Process:

Approval Status:

Treatment Assignment Data

Participation or Assignment Information:

Yes

Description:

Data Obtained by the Study Researchers?

Data Previously Used?

Data Access:

Data Obtained by the Study Researchers?

Data Approval Process:

Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

Upload Study Materials:

Registration Category

Registration Category:

Prospective, Category 1: Data for measuring impacts have not been collected

Completion

Completion Overview

Intervention Completion Date:

Data Collection Completion Date:

Unit of Analysis:

Clusters in Final Sample:

Total Observations in Final Sample:

Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:

Preliminary Report URL:

Summary of Findings:

Paper:

Paper Summary:

Paper Citation:

Data Availability

Data Availability (Primary Data):

Date of Data Availability:

Data URL or Contact:

Access procedure:

Other Materials

Survey:

Survey Instrument Links or Contact:

Program Files:

Program Files Links or Contact:

External Link:

External Link Description:

Description of Changes:

Study Stopped

Date:

Reason: