HIVNCT01688167
Increasing Availability and Acceptability of Circumcision in Zambia
A study testing MC and sexual risk reduction in people with HIV, run by University of Miami at 1 site in Zambia.
Trial summary
This study proposes to balance supply and demand of male circumcision through a systematic scale-up of coordinated biomedical surgical and behavioral counseling services. The study will compare the combined biobehavioral sexual risk reduction intervention to the standard of care, which focuses exclusively on the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- MC and sexual risk reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,468 participants
- Where
- 1 siteZambia
- Study dates
- Jan 2012to Nov 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV negative
- Uncircumcised male
- 18+ years of age
- Able to understand and sign informed consent in English, Bemba, or Nyanja
- Have not requested male circumcision services at the time of or following VCT
- Female partners of enrolled males are invited to participate
Who cannot join
- Men seeking circumcision services are not eligible for this study
- Men with genital abnormalities requiring MC, e.g. balanitis (inflammation of the preputial skin), posthitis (inflammation of the glans penis; common in patients with diabetes), phimosis (scarring of the distal margins of the foreskin) resulting from chronic balanitis, paraphimosis (the inability to pull the retracted foreskin back over the glans) or diseases of the foreskin, including localized carcinoma are not eligible for this study
- Men with congenital or acquired penile abnormalities that require the preputial skin for generative repair, such as hypospadias (urethra exits from underside of penis) are not eligible to participate
- Participants unable to provide informed consent will not be eligible.
Trial locations and contacts
1 site in 1 country.
About this study
This study proposes to balance supply and demand of male circumcision through a systematic scale-up of coordinated biomedical surgical and behavioral counseling services. The study will compare the combined biobehavioral sexual risk reduction intervention to the standard of care, which focuses exclusively on the provision of circumcision services alone, with the goal of optimizing both local and national HIV prevention efforts.
- Conditions
- HIV
- Being tested
- MC and sexual risk reduction
- Keywords
- HIV, Male circumcision, Sexual risk reduction, Stages of change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC and sexual risk reductionBehavioural
Four group counselling sessions focused on male circumcision and sexual risk reduction
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Experimental condition clinics offer the MC and sexual risk reduction intervention: four group counseling sessions focused on male circumcision and sexual risk reduction. Receives: Behavioral: MC and sexual risk reduction |
| Standard of Care | No intervention | Male participants in the standard of care control condition CHCs will receive counseling per the VCT protocol guidelines. Participants will attend four video-based time-equivalent "attention-control" group sessions on endemic disease prevention strategies (e.g., TB, malaria, cholera, waterborne diseases). Female partners will be invited to participate in a similar four session program devoted to endemic disease risk reduction. |
| Observational | No intervention | 3 CHC sites will be randomly assigned as "observation only;" only aggregated clinic VCT and circumcision data will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in likelihood of undergoing male circumcision across the study using stages of change model
Readiness to undergo male circumcision will be assessed using the stages of change model (pre-contemplation, contemplation, preparation, action, maintenance). Intervention and attention control conditions will be compared at baseline, immediately following intervention, and 6 and 12 months post-intervention.
Measured: Baseline, Average of 1 month post-baseline, 6 month and 12 month follow-up
Secondary outcomes (1)
Uptake of male circumcision
To determine if participants in the sexual risk reduction/MC promotion intervention (experimental condition) will be more likely to shift to the "Action" stage (undergo circumcision), in comparison with participants having identical MC services available plus usual care (attention control condition).
Measured: From the date of study enrollment to the date male circumcision is performed or study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,468 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Stephen Weiss, University of Miami
- Investigators
- Stephen M Weiss, PhD, Study chair, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688167
- Sponsor's protocol ID
- 20110290
- Other IDs
- R01MH095539
- Status last verified
- Jun 2022
- First submitted
- 11 Sep 2012
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Weiss SM, Zulu R, Jones DL, Redding CA, Cook R, Chitalu N. The Spear and Shield intervention to increase the availability and acceptability of voluntary medical male circumcision in Zambia: a cluster randomised controlled trial. Lancet HIV. 2015 May;2(5):e181-9. doi: 10.1016/S2352-3018(15)00042-9.
PubMed 26120594Jones DL, Lopez M, Simons H, Diaz-Gloster M, Tobin JN, Weiss SM. Translation of a comprehensive health behavior intervention for women living with HIV: the SMART/EST Women's Program. Transl Behav Med. 2013 Dec;3(4):416-25. doi: 10.1007/s13142-013-0213-4.
PubMed 24294330Jones D, Weiss S, Chitalu N. HIV Prevention in Resource Limited Settings: A Case Study of Challenges and Opportunities for Implementation. Int J Behav Med. 2015 Jun;22(3):384-92. doi: 10.1007/s12529-014-9397-3.
PubMed 24604206Cook R, Jones D, Redding CA, Zulu R, Chitalu N, Weiss SM. Female Partner Acceptance as a Predictor of Men's Readiness to Undergo Voluntary Medical Male Circumcision in Zambia: The Spear and Shield Project. AIDS Behav. 2016 Nov;20(11):2503-2513. doi: 10.1007/s10461-015-1079-x.
PubMed 25931242Redding CA, Jones D, Zulu R, Chitalu N, Cook R, Weiss SM. Stages of Change for Voluntary Medical Male Circumcision and Sexual Risk Behavior in Uncircumcised Zambian Men: The Spear and Shield Project. Int J Behav Med. 2015 Dec;22(6):799-806. doi: 10.1007/s12529-015-9485-z.
PubMed 25896876
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Availability and Acceptability of Circumcision in Zambia
- ClinicalTrials.gov ID
- NCT01688167
- Acronym / sponsor ID
- 20110290
- Conditions
- HIV
- Keywords
- HIV, Male circumcision, Sexual risk reduction, Stages of change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,468 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 Sep 2012 (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.
This study proposes to balance supply and demand of male circumcision through a systematic scale-up of coordinated biomedical surgical and behavioral counseling services. The study will compare the combined biobehavioral sexual risk reduction intervention to the standard of care, which focuses exclusively on the provision of circumcision services alone, with the goal of optimizing both local and national HIV prevention efforts.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MC and sexual risk reductionExperimental condition clinics offer the MC and sexual risk reduction intervention: four group counseling sessions focused on male circumcision and sexual risk reduction. |
| Standard of Care | No intervention | –Male participants in the standard of care control condition CHCs will receive counseling per the VCT protocol guidelines. Participants will attend four video-based time-equivalent "attention-control" group sessions on endemic disease prevention strategies (e.g., TB, malaria, cholera, waterborne diseases). Female partners will be invited to participate in a similar four session program devoted to endemic disease risk reduction. |
| Observational | No intervention | –3 CHC sites will be randomly assigned as "observation only;" only aggregated clinic VCT and circumcision data will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV negative
- Uncircumcised male
- 18+ years of age
- Able to understand and sign informed consent in English, Bemba, or Nyanja
- Have not requested male circumcision services at the time of or following VCT
Key exclusion criteria (4 listed)
- Men seeking circumcision services are not eligible for this study
- Men with genital abnormalities requiring MC, e.g. balanitis (inflammation of the preputial skin), posthitis (inflammation of the glans penis; common in patients with diabetes), phimosis (scarring of the distal margins of the foreskin) resulting from chronic balanitis, paraphimosis (the inability to pull the retracted foreskin back over the glans) or diseases of the foreskin, including localized carcinoma are not eligible for this study
- Men with congenital or acquired penile abnormalities that require the preputial skin for generative repair, such as hypospadias (urethra exits from underside of penis) are not eligible to participate
- Participants unable to provide informed consent will not be eligible.
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 |
|---|---|---|
| MC and sexual risk reductionFour group counselling sessions focused on male circumcision and sexual risk reduction | Behavioural | Intervention |
Primary outcome
Change in likelihood of undergoing male circumcision across the study using stages of change model
Time frame: Baseline, Average of 1 month post-baseline, 6 month and 12 month follow-up
Readiness to undergo male circumcision will be assessed using the stages of change model (pre-contemplation, contemplation, preparation, action, maintenance). Intervention and attention control conditions will be compared at baseline, immediately following intervention, and 6 and 12 months post-intervention.
1 secondary outcome
Uptake of male circumcision
Time frame: From the date of study enrollment to the date male circumcision is performed or study completion.
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 24 Jun 2022.
- Background: PubMed 26120594Weiss SM, Zulu R, Jones DL, Redding CA, Cook R, Chitalu N. The Spear and Shield intervention to increase the availability and acceptability of voluntary medical male circumcision in Zambia: a cluster randomised controlled trial. Lancet HIV. 2015 May;2(5):e181-9. doi: 10.1016/S2352-3018(15)00042-9.
- Background: PubMed 24294330Jones DL, Lopez M, Simons H, Diaz-Gloster M, Tobin JN, Weiss SM. Translation of a comprehensive health behavior intervention for women living with HIV: the SMART/EST Women's Program. Transl Behav Med. 2013 Dec;3(4):416-25. doi: 10.1007/s13142-013-0213-4.
- Background: PubMed 24604206Jones D, Weiss S, Chitalu N. HIV Prevention in Resource Limited Settings: A Case Study of Challenges and Opportunities for Implementation. Int J Behav Med. 2015 Jun;22(3):384-92. doi: 10.1007/s12529-014-9397-3.
- Background: PubMed 25931242Cook R, Jones D, Redding CA, Zulu R, Chitalu N, Weiss SM. Female Partner Acceptance as a Predictor of Men's Readiness to Undergo Voluntary Medical Male Circumcision in Zambia: The Spear and Shield Project. AIDS Behav. 2016 Nov;20(11):2503-2513. doi: 10.1007/s10461-015-1079-x.
- Background: PubMed 25896876Redding CA, Jones D, Zulu R, Chitalu N, Cook R, Weiss SM. Stages of Change for Voluntary Medical Male Circumcision and Sexual Risk Behavior in Uncircumcised Zambian Men: The Spear and Shield Project. Int J Behav Med. 2015 Dec;22(6):799-806. doi: 10.1007/s12529-015-9485-z.
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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.
Stephen M Weiss, PhD study chair
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MC and sexual risk reduction in people with HIV, run by University of Miami at 1 site in Zambia.
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 6 inclusion and 4 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 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. 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?
Change in likelihood of undergoing male circumcision across the study using stages of change model (time frame: Baseline, Average of 1 month post-baseline, 6 month and 12 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01688167, which also lists 5 linked publications.
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 24 Jun 2022.