HIVNCT02376348
Male Circumcision Against HIV Hukomboa
A study testing A targeted demand creation Activities in people with HIV, run by National Institute for Medical Research, Tanzania at 2 sites in Tanzania.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- A targeted demand creation Activities
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,782 participants
- Where
- 2 sitesTanzania
- Study dates
- 3 Feb 2014to 28 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 50 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Show all 9Show fewer
- Clients
- Uncircumcised males
- given an informed consent to participate in the study
Who cannot join
- 1) Circumcised males
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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:
- 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.
- Conditions
- HIV
- Being tested
- A targeted demand creation Activities
- Keywords
- VMMC, Adult males, HIV Prevention, Africa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A targeted demand creation ActivitiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Individuals receiving the standard Ministry of Health Package |
| Intervention | Experimental | Individuals receiving the targeted demand creation strategy to increase adult men taking up VMMC Receives: Behavioral: A targeted demand creation Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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 .
Measured: 5-6 weeks of demand creation activities
Secondary outcomes (1)
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)
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
Measured: 5-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study start3 Feb 2014
- Primary completion4 May 2015
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 10,782 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Medical Research, Tanzania
- Sponsor type
- Other government
- Collaborators
- London School of Hygiene and Tropical Medicine, Jhpiego, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Mwita Wambura, National Institute for Medical Research, Tanzania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376348
- Sponsor's protocol ID
- GH 005-000513
- Status last verified
- Oct 2017
- First submitted
- 24 Feb 2015
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02376348
- Acronym / sponsor ID
- GH 005-000513
- Conditions
- HIV
- Keywords
- VMMC, Adult males, HIV Prevention, Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,782 participants (actual)
- Lead sponsor
- National Institute for Medical Research, TanzaniaOther government
- Collaborators
- London School of Hygiene and Tropical Medicine, Jhpiego, Centers for Disease Control and Prevention
- Study start
- 3 Feb 2014 (actual)
- Primary completion
- 4 May 2015 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Individuals receiving the standard Ministry of Health Package |
| Intervention | Experimental | Behavioral: A targeted demand creation ActivitiesIndividuals receiving the targeted demand creation strategy to increase adult men taking up VMMC |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) Circumcised males
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A targeted demand creation ActivitiesSites 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. | Behavioural | Intervention |
Primary outcome
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 .
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A targeted demand creation Activities in people with HIV, run by National Institute for Medical Research, Tanzania at 2 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.