Clinical Trials

MainTitle

Male Circumcision Against HIV Hukomboa

This study has been completed
Sponsor
National Institute for Medical Research, Tanzania

Collaborator
London School of Hygiene and Tropical Medicine
Jhpiego
Centers for Disease Control and Prevention

Information provided by (Responsible Party)
Mwita Wambura, National Institute for Medical Research, Tanzania

ClinicalTrials.gov Identifier
NCT02376348

First received: February 24, 2015
Last updated: October 5, 2017
Last Verified: October 2017
History of Changes
Purpose

Purpose

Tanzania launched a National Strategy for scaling-up voluntary medical male circumcision in 2010, and aims to circumcise 2.8 million males by 2015. In September 2009, Jhpiego's Maternal and Child Health Integrated Program (MCHIP) launched a PEPFAR-funded voluntary medical male circumcision (VMMC) program which has circumcised over 110,000 males in Njombe and Iringa regions by June 2012. In line with the national strategy, the target age for the program was 10-34 years, but 80% of clients were aged 10-19 years. There is an urgent need to increase the proportion of older men (aged 20 years and above) who become circumcised, to have greatest impact on the HIV epidemic.

Condition Intervention
HIV

Behavioral : A targeted demand creation Activities

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Health Services Research
Official Title: Increasing Uptake of Voluntary Medical Male Circumcision Among Men Aged 20-34 Years in Njombe & Tabora Regions, Tanzania: A Cluster Randomised Controlled Trial

Further study details as provided by Mwita Wambura, National Institute for Medical Research, Tanzania:

Primary Outcome Measures

  • Impact of intervention on proportion of male clients aged 20-34 years (ratio of the geometric mean proportion of clients aged 20-34 years in the 10 intervention facilities versus that in the 10 control facilities) [ Time Frame: 5-6 weeks of demand creation activities ]
    Cluster-level summary methods will be used to assess the impact of the intervention[19]. The primary outcome will be the unadjusted "prevalence ratio", estimated as the .
Secondary Outcome Measures:
  • Comparison of population attending for circumcision with general male population (proportion of males reporting the below risk factors will be compared to proportion of males reporting the same in the 2010 Tanzania Demographic and Health Survey) [ Time Frame: 5-6 weeks ]
    In this study, high risk males will be males reporting two or more partners in the last 12 months; reporting unprotected sex with non-married and non-cohabiting sexual partners and men who agreed on a price and paid anyone in exchange for having sexual intercourse. The proportion of males reporting the above risk factors will be compared to proportion of males reporting the same in the 2010 Tanzania Demographic and Health Survey

Enrollment: 10782
Study Start Date: February 3, 2014
Study Completion Date: February 28, 2017
Primary Completion Date: May 4, 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
No Intervention: Control
Individuals receiving the standard Ministry of Health Package
Experimental: Intervention
Individuals receiving the targeted demand creation strategy to increase adult men taking up VMMC
Behavioral: A targeted demand creation Activities

Sites randomized to the intervention arm will receive all activities in the control arm, plus additional demand-creation communication messages that focus on the non-HIV benefits of VMMC and the voluntary nature of HIV testing prior to VMMC ii) use of already circumcised men from the community as auxiliary peer promoters, iii) separate waiting and group education areas for men aged 20 years and above during service delivery, iv) engagement of female partners in community-based demand creation and education and counselling about wound healing and post-circumcision abstinence.

Detailed Description:

In order to maintain high client flow in sites, the Iringa service delivery model is flexible in terms of how, where and when services are delivered. Approaches include:
i) Static sites: These sites offer regularly scheduled VMMC services several days a week. Services are offered year round rather than periodically. Volume tends to be low (20-50 clients a week).
ii) Outreach sites: VMMC services are offered periodically at health facilities. A team composed of providers 'borrowed' from other regional health facilities visits the sites for a 2-3 week period and offers VMMC 6 days a week. This is typically a high volume setting, in which 40-120 circumcisions are performed a day, depending on the number of beds which can be set up.
iii) Campaign: Campaigns happen 2-3 times a year, and may include both static and outreach sites. Campaigns are high volume, concerted approaches to VMMC where multiple facilities are running coordinated VMMC service delivery.
These services are complemented by demand creation activities (mass media, interpersonal activities and outreach activities) designed to recruit and motivate new clients, and a text messaging information system which is advertised through radio and other means, providing potential clients advice on where VMMC is offered, the benefits of VMMC, and post-surgery reminders for wound care, follow-up visits and safer sex. The intensity of the demand creation depends on the size of campaign. In general, static sites do not have any demand creation but outreach and campaigns do.
The proposed research will take place at outreach sites; however, the study will not stop on-going VMMC services provided at static sites to young men but rather encourage older males to come as well as young boys. Outreach sites have larger potential client size than static sites because the catchment area round the outreach sites have generally not had access to VMMC in the past and clients show up in large numbers to be served, whereas in static sites, clients trickle through in lower volume. Outreach activities can be scheduled at the convenience of the program. By using outreach activities, the proposed research, can be more easily scheduled into the study's data collection timeframe (compared to campaign sites which are on a highly prescribed schedule).
QUALITATIVE ASSESSMENT FINDINGS In February 2011, Jhpiego co-investigators on this study conducted qualitative research in 3 districtsin Iringa (Iringa Municipality, Njombe and Mafinga), with the aim of understanding men's and women's views on appropriate age for circumcision, perceptions on circumcision, barriers and facilitators to older men seeking circumcision, and seasonality[9]. Identified barriers among older men included shame associated with older men getting circumcised, as it was seen to be an age-inappropriate activity, concerns of older men about their partners being faithful to them during the healing period, concerns about loss of income during the healing period, and concern around erections causing damage to the penis or delay wound healing. The facilitating factors included that circumcised men were seen as cleaner, safer from diseases, and more sexually desirable to women.
Exploration of preferences for service delivery showed that participants had a strong preference for a model in which boys and men were provided separate services. There was also support for all-male service providers to alleviate concerns about embarrassment at having women view/touch the penis and the possibility that an erection could occur during the procedure. There was little support for including female partners accompanying their partners to the facilities. There was a marked preference for the cold season (June-August) for three reasons: fewer farming responsibilities, school being out, and a cold temperature which is perceived to facilitate wound healing.
Based on this research, we anticipate that the targeted VMMC strategy evaluated in this research will include demand-creation strategies using focused informational communication messages for men aged over 20 years, and increased information and education for female partners. Service delivery strategies may include separate services for men versus boys and increasing the role of male service providers. The targeting strategy will be finalised during Study 1, and implemented and evaluated during Study 2.

Eligibility

Eligibility

Ages Eligible for Study: 10 Years to 50 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:
Sites

  • an outreach VMMC health facility,
  • a site selected by Jhpiego for outreach VMMC campaign,
  • a site that has not had previous outreach services (to enable the results to be generalizable to future new outreach) or have not had VMMC outreach services in the previous 6 months, and
  • physically distant from other potential study sites to minimise contamination (spill over) of activities in the intervention communities into control communities.

  • The parent sites from different clusters must be at least 20km away from each other, regardless of whether they are randomised to be control or intervention sites.
    Clients ~#o1~ Uncircumcised males
  • given an informed consent to participate in the study

Exclusion Criteria:

    1) Circumcised males

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02376348

Locations

Tanzania
Njombe
Njombe, Tanzania
Tabora
Tabora, Tanzania

Sponsors and Collaborators

National Institute for Medical Research, Tanzania
London School of Hygiene and Tropical Medicine
Jhpiego
Centers for Disease Control and Prevention
More Information

More Information


Responsible Party: Mwita Wambura, Researcher, National Institute for Medical Research, Tanzania  
ClinicalTrials.gov Identifier: NCT02376348   History of Changes  
Other Study ID Numbers: GH 005-000513  
Study First Received: February 24, 2015  
Last Updated: October 5, 2017  

Keywords provided by Mwita Wambura, National Institute for Medical Research, Tanzania:

VMMC
Adult males
HIV Prevention
Africa

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.