HIV InfectionInvolvMaleUgNCT01144234
Male Involvement in Antenatal Care and the Prevention Programme of Mother-to-child Transmission of HIV in Uganda
A study testing Invitation letter for male spouse and Information letter in people with HIV Infection, run by Centre For International Health at 1 site in Uganda.
Trial summary
HIV /AIDS is a major public health problem in Uganda. The prevention of mother to child transmission of HIV/ AIDS (PMTCT) was launched in Uganda in November 2001 and in Mbale Hospital in May 2002. Currently, PMTCT services have been integrated into mainstream antenatal care services throughout the country. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Invitation letter for male spouse and Information letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,060 participants
- Where
- 1 siteUganda
- Study dates
- Jun 2010to Dec 2010
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- New antenatal mothers (attendees) at Mbale regional referral hospital
- Acceptance to attend at least two subsequent antenatal visits at Mbale hospital
Who cannot join
- Women attending with their spouses at the first ANC visit
- Refusal to take the letter to her spouse
- Women with inaccessible spouses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Facility-based Intervention to Increase Male Involvement in Antenatal Care and the Prevention Programme of Mother-to-child Transmission of HIV in Eastern Uganda
HIV /AIDS is a major public health problem in Uganda. The prevention of mother to child transmission of HIV/ AIDS (PMTCT) was launched in Uganda in November 2001 and in Mbale Hospital in May 2002. Currently, PMTCT services have been integrated into mainstream antenatal care services throughout the country.
Though engaging men as partners is a critical component in the PMTCT programme, their involvement has been low. Measures to increase male partner involvement in the PMTCT programmes have not been explored in Uganda.
Read more
Objectives: To determine the effect of a written invitation letter to the spouses of women, attending their first antenatal visit on: (a) couple attendance at subsequent antenatal clinic visits; and (b) couple acceptance of HIV testing.
Study site: The study will be carried out at Mbale Regional Referral Hospital in eastern Uganda
Study design: A randomised clinical trial among 1060 (530 intervention and 530 control) new antenatal attendees. The intervention will be a written invitation letter to their spouses.
Outcome measures: The main outcome measure is the proportion of pregnant women who come with their partners for ANC at the subsequent antenatal visit.
Utility: The results of this study will be utilised in re-orienting the ANC services to encourage male participation and hopefully improve the uptake of the PMTCT services at Mbale Regional Referral Hospital.
- Conditions
- HIV Infection
- Being tested
- Invitation letter for male spouse, Information letter
- Keywords
- Prevention of mother-to-child transmission of HIV-1
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation letter for male spouseBehavioural
In this arm the pregnant women got an invitation letter for the spouse to attend at the next antenatal visit
Information letterBehavioural
In this arm the pregnant women got an information letter
| Study group | Role | What they receive |
|---|---|---|
| Invitation letter to male spouse | Experimental | In this arm the pregnant women got an invitation letter for the spouse to attend at the next antenatal visit Receives: Behavioral: Invitation letter for male spouse |
| Information letter | Placebo comparator | In this arm the pregnant women got an information letter about antenatal care. Receives: Behavioral: Information letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of pregnant women who come with their partners
The proportion of pregnant women who come with their partners for antenatal care at the subsequent antenatal visit.
Measured: follow-up visit 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,060 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre For International Health
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University
- Responsible party
- Sponsor
- Investigators
- James K Tumwine, MD, PhD, Study chair, Makerere UniversityThorkild Tylleskar, MD, PhD, Study chair, Centre for International Health, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144234
- Sponsor's protocol ID
- InvolvMaleUg
- Acronym
- InvolvMaleUg
- Status last verified
- Jan 2013
- First submitted
- 14 Jun 2010
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Byamugisha R, Astrom AN, Ndeezi G, Karamagi CA, Tylleskar T, Tumwine JK. Male partner antenatal attendance and HIV testing in eastern Uganda: a randomized facility-based intervention trial. J Int AIDS Soc. 2011 Sep 13;14:43. doi: 10.1186/1758-2652-14-43.
PubMed 21914207Byamugisha R, Tumwine JK, Semiyaga N, Tylleskar T. Determinants of male involvement in the prevention of mother-to-child transmission of HIV programme in Eastern Uganda: a cross-sectional survey. Reprod Health. 2010 Jun 23;7:12. doi: 10.1186/1742-4755-7-12.
PubMed 20573250
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facility-based Intervention to Increase Male Involvement in Antenatal Care and the Prevention Programme of Mother-to-child Transmission of HIV in Eastern Uganda
- ClinicalTrials.gov ID
- NCT01144234
- Acronym / sponsor ID
- InvolvMaleUg / InvolvMaleUg
- Conditions
- HIV Infection
- Keywords
- Prevention of mother-to-child transmission of HIV-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,060 participants (actual)
- Lead sponsor
- Centre For International HealthUniversity, hospital or other
- Collaborators
- Makerere University
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Jun 2010 (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.
HIV /AIDS is a major public health problem in Uganda. The prevention of mother to child transmission of HIV/ AIDS (PMTCT) was launched in Uganda in November 2001 and in Mbale Hospital in May 2002. Currently, PMTCT services have been integrated into mainstream antenatal care services throughout the country.
Though engaging men as partners is a critical component in the PMTCT programme, their involvement has been low. Measures to increase male partner involvement in the PMTCT programmes have not been explored in Uganda.
Objectives: To determine the effect of a written invitation letter to the spouses of women, attending their first antenatal visit on: (a) couple attendance at subsequent antenatal clinic visits; and (b) couple acceptance of HIV testing.
Study site: The study will be carried out at Mbale Regional Referral Hospital in eastern Uganda
Study design: A randomised clinical trial among 1060 (530 intervention and 530 control) new antenatal attendees. The intervention will be a written invitation letter to their spouses.
Outcome measures: The main outcome measure is the proportion of pregnant women who come with their partners for ANC at the subsequent antenatal visit.
Utility: The results of this study will be utilised in re-orienting the ANC services to encourage male participation and hopefully improve the uptake of the PMTCT services at Mbale Regional Referral Hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invitation letter to male spouse | Experimental | Behavioral: Invitation letter for male spouseIn this arm the pregnant women got an invitation letter for the spouse to attend at the next antenatal visit |
| Information letter | Placebo comparator | Behavioral: Information letterIn this arm the pregnant women got an information letter about antenatal care. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- New antenatal mothers (attendees) at Mbale regional referral hospital
- Acceptance to attend at least two subsequent antenatal visits at Mbale hospital
Key exclusion criteria (3 listed)
- Women attending with their spouses at the first ANC visit
- Refusal to take the letter to her spouse
- Women with inaccessible spouses
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 |
|---|---|---|
| Invitation letter for male spouseIn this arm the pregnant women got an invitation letter for the spouse to attend at the next antenatal visit | Behavioural | Invitation letter to male spouse |
| Information letterIn this arm the pregnant women got an information letter | Behavioural | Information letter |
Primary outcome
proportion of pregnant women who come with their partners
Time frame: follow-up visit 4 weeks later
The proportion of pregnant women who come with their partners for antenatal care at the subsequent antenatal visit.
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 15 Jan 2013.
- Results publication: PubMed 21914207Byamugisha R, Astrom AN, Ndeezi G, Karamagi CA, Tylleskar T, Tumwine JK. Male partner antenatal attendance and HIV testing in eastern Uganda: a randomized facility-based intervention trial. J Int AIDS Soc. 2011 Sep 13;14:43. doi: 10.1186/1758-2652-14-43.
- Results publication: PubMed 20573250Byamugisha R, Tumwine JK, Semiyaga N, Tylleskar T. Determinants of male involvement in the prevention of mother-to-child transmission of HIV programme in Eastern Uganda: a cross-sectional survey. Reprod Health. 2010 Jun 23;7:12. doi: 10.1186/1742-4755-7-12.
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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.
James K Tumwine, MD, PhD study chair
Makerere University
Thorkild Tylleskar, MD, PhD study chair
Centre for International Health, University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invitation letter for male spouse and Information letter in people with HIV Infection, run by Centre For International Health at 1 site in Uganda.
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 2 inclusion and 3 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 15 Jan 2013. 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 Uganda. 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. Some participants in this study may receive a placebo. 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?
proportion of pregnant women who come with their partners (time frame: follow-up visit 4 weeks later). 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 NCT01144234, which also lists 2 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 15 Jan 2013.