HIVNCT01903889
Male Engagement in PMTCT Services
A study testing clinic based intervention and clinic and community based intervention in people with HIV, run by FHI 360 at 7 sites in Uganda.
Trial summary
The study employs a quasi-experimental design in 8 public health centers in southwest Uganda offering care and treatment (C\&T) services. In 4 health centers, a basic intervention is introduced, whereby HIV/AIDS providers are trained on contraception for HIV-positive women. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- clinic based intervention and clinic and community based intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,806 participants
- Where
- 7 sitesUganda
- Study dates
- Jan 2013to Aug 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- female participants
- attending pre-ART and ART services;
- non-pregnant women;
- age 18 to 45;
- sexually active with any type of partner within the past 3 months.
- male participants
Show all 9Show fewer
- attending pre-ART and ART services;
- age 18 to 60;
- sexually active within the past 3 months with partner, either co-habiting partner or steady, with partner aged 18 to 45 and is not pregnant.
Who cannot join
- For the post-intervention interviews, clients who initiated Care \& Treatment services in one of the intervention facilities less than 3 months prior will be excluded given insufficient exposure to the intervention.
- Clients unable to speak Runyankole, the dominant language in the region, will also be excluded
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Uganda7 sites
Bukinda Health Center
Kabale
Kamkira Health Center
Kabale
Kamwezi Health Center
Kabale
Maziba Health Center
Kabale
Mparo Health Center
Kabale
Muko Health Center
Kabale
Rubaya Health Center
Kabale
About this study
Official title: Promoting Constructive Male Engagement to Increase Use of Prevention of Mother to Child Transmission (PMTCT) Services
The study employs a quasi-experimental design in 8 public health centers in southwest Uganda offering care and treatment (C\&T) services. In 4 health centers, a basic intervention is introduced, whereby HIV/AIDS providers are trained on contraception for HIV-positive women. They are charged with counseling C\&T clients on FP; offering condoms, pills and injectables; and referring clients for other FP methods. In the other 4 health centers, the basic intervention is introduced along with an intervention for constructive male engagement in HIV and FP services. This includes training of C\&T providers on gender-based influences on health behaviors; provision of couples' HIV testing and FP counseling services; and community-based education for men to promote gender equitable norms and male participation in health services.
Read the detailed description
This study will be conducted in Kabale District, Uganda, a rural district where prevention of mother to child transmission (PMTCT) and care and treatment (C\&T) services are offered in eight public sector health facilities. The primary aim of this study is to test an intervention for increasing use of the full spectrum of PMTCT services, including family planning (FP), through enhanced constructive male involvement in reproductive health decision making. This aim will be accomplished by conducting a cluster randomized trial, whereby a "constructive male engagement" intervention package will be introduced in four randomly selected health centers and surrounding communities; the other four sites will serve as comparisons. Pre- and post-intervention cross sectional surveys will be conducted with male and female C\&T clients to assess intervention effectiveness, measured in terms of dual method use. In addition to the male engagement intervention, reinforcements will be introduced in all eight participating facilities to enhance providers' capacity to serve the FP needs of C\&T clients. We hypothesize that the percentage of clients reporting dual method use will increase slightly in all facilities as a result of this "HIV-FP integration intervention." To measure the independent effect of the reinforcements, the study will compare contraceptive knowledge, attitudes, and behaviors of clients measured pre- and post-intervention in the comparison sites only, in the absence of the male engagement intervention. We further hypothesize that improvements will be incrementally greater in the four facilities exposed to the additional constructive male engagement intervention.
The study will include additional data collection and analyses to support secondary objectives.
- Services statistics will be tracked to assess changes in uptake and continuation of PMTCT services.
- The study will include a qualitative component to investigate condom use behaviors. Based on other investigations, it is anticipated that rates of self-reported condom use among C\&T clients will be high. To examine those behaviors more closely and to circumvent courtesy bias often associated with quantitative surveys, the study will conduct individual in-depth interviews with a subset of female and male C\&T clients reporting consistent condom use.
- The constructive male engagement intervention will comprise both community- and clinic-based components. To assess the effectiveness of the community-based men's workshops, the study will assess changes in knowledge, attitudes, and behaviors among men exposed to the community-based intervention by surveying them before and 4 months after community-level training is held. Interviews will assess knowledge and attitudes related to FP and HIV services (PMTCT in particular), with particular focus on gender norms supporting constructive male involvement. Interviews will also examine clients' recollection of services and messages received in the health center, along with their direct and indirect exposure to the community-based men's workshops.
- The effectiveness of the intervention components aimed at reinforcing the capacity of clinic-based providers to serve the family planning needs of HIV-positive individuals and to engage male partners constructively in FP decision making will be assessed in terms of its impact on C\&T clients. Specifically, interviews with C\&T clients will include questions about messages communicated by providers and service delivery practices reflecting successful implementation of the intervention components.
- Finally, the study will examine the resource requirements for adding each the interventions (reinforcement of FP and male involvement) into C\&T services. Based on costs of the piloted interventions, the study will arrive at an estimate of the cost of implementing these interventions at scale under the direction of the district management team.
- Conditions
- HIV
- Being tested
- clinic based intervention, clinic and community based intervention
- Keywords
- AE adverse event, AIDS acquired immunodeficiency syndrome, ALT (SGPT) alanine aminotransferase, ART antiretroviral therapy, AST (SGOT) aspartate aminotransferase, DCF data collection forms, DMC Data Monitoring Committee, FDA (U.S.) Food and Drug Administration, GCP Good Clinical Practice guidelines, HB sAg Hepatitis B surface antigen, ICH International Conference of Harmonization, IND Investigational New Drug Application, IRB Institutional Review Board, IU International units, mg milligram(s), mm3 cubic millimeter(s), PCR polymerase chain reaction, SAE serious adverse event, µg microgram, ULN upper limit of the normal range
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinic based interventionOther
counseling C\&T clients on FP; offering condoms, pills and injectables; and referring clients for other FP methods
clinic and community based interventionOther
basic intervention is introduced along with an intervention for constructive male engagement in HIV and FP services
| Study group | Role | What they receive |
|---|---|---|
| Clinic based intervention | Active comparator | basic intervention is introduced, whereby HIV/AIDS providers are trained on contraception for HIV-positive women. They are charged with counseling C\&T clients on FP; offering condoms, pills and injectables; and referring clients for other FP methods Receives: Other: clinic based intervention |
| clinic and community based intervention | Experimental | The basic intervention is introduced along with an intervention for constructive male engagement in HIV and FP services. This includes training of C\&T providers on gender-based influences on health behaviors; provision of couples' HIV testing and FP counseling services; and community-based education for men to promote gender equitable norms and male participation in health services. Receives: Other: clinic and community based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of an intervention aimed at constructively engaging men in FP decision making
Dual method use among couples with at least one partner using C\&T services
Measured: 12 months
Secondary outcomes (5)
To measure changes over time in uptake of Prong 3 PMTCT services, comparing facilities that are and are not exposed to the constructive male engagement intervention
Number of new ANC clients
Measured: 6 months
To assess the effect of reinforcements introduced to enhance C&T providers' capacity to serve the FP needs of HIV-positive clients, as reflected in C&T clients' knowledge, attitudes, and behaviors related to FP.
Dual method use among couples with at least one partner using C\&T services 2) Knowledge and attitudes related to FP
Measured: 12 months
To explore condom use dynamics and the factors favoring and discouraging consistent use by cohabiting couples
- Consistency of condom use 2) Factors encouraging and impeding consistent condom use
Measured: 1 month
To evaluate men's knowledge and attitudes related to gender norms and FP and HIV services before and after participation in a 10-week community education and mobilization program.
- Perspectives on acceptable gender norms 2) Knowledge, attitudes, and behaviors related to use of family planning and HIV services.
Measured: 10 months
To document the technical, human, and material resources required to implement the study interventions and to estimate the financial cost of implementation at scale.
Cost of implementing HIV-FP integration intervention and male engagement intervention.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completionAug 2014
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,806 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Elizabeth Glaser Pediatric AIDS Foundation, Mbarara University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Theresa Hoke, Ph.D., MPH, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903889
- Sponsor's protocol ID
- 10385
- Status last verified
- Jan 2015
- First submitted
- 17 Jul 2013
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Constructive Male Engagement to Increase Use of Prevention of Mother to Child Transmission (PMTCT) Services
- ClinicalTrials.gov ID
- NCT01903889
- Acronym / sponsor ID
- 10385
- Conditions
- HIV
- Keywords
- AE adverse event, AIDS acquired immunodeficiency syndrome, ALT (SGPT) alanine aminotransferase, ART antiretroviral therapy, AST (SGOT) aspartate aminotransferase, DCF data collection forms, DMC Data Monitoring Committee, FDA (U.S.) Food and Drug Administration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,806 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Elizabeth Glaser Pediatric AIDS Foundation, Mbarara University of Science and Technology
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 19 Jul 2013 (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.
The study employs a quasi-experimental design in 8 public health centers in southwest Uganda offering care and treatment (C\&T) services. In 4 health centers, a basic intervention is introduced, whereby HIV/AIDS providers are trained on contraception for HIV-positive women. They are charged with counseling C\&T clients on FP; offering condoms, pills and injectables; and referring clients for other FP methods. In the other 4 health centers, the basic intervention is introduced along with an intervention for constructive male engagement in HIV and FP services. This includes training of C\&T providers on gender-based influences on health behaviors; provision of couples' HIV testing and FP counseling services; and community-based education for men to promote gender equitable norms and male participation in health services.
Detailed description
This study will be conducted in Kabale District, Uganda, a rural district where prevention of mother to child transmission (PMTCT) and care and treatment (C\&T) services are offered in eight public sector health facilities. The primary aim of this study is to test an intervention for increasing use of the full spectrum of PMTCT services, including family planning (FP), through enhanced constructive male involvement in reproductive health decision making. This aim will be accomplished by conducting a cluster randomized trial, whereby a "constructive male engagement" intervention package will be introduced in four randomly selected health centers and surrounding communities; the other four sites will serve as comparisons. Pre- and post-intervention cross sectional surveys will be conducted with male and female C\&T clients to assess intervention effectiveness, measured in terms of dual method use. In addition to the male engagement intervention, reinforcements will be introduced in all eight participating facilities to enhance providers' capacity to serve the FP needs of C\&T clients. We hypothesize that the percentage of clients reporting dual method use will increase slightly in all facilities as a result of this "HIV-FP integration intervention." To measure the independent effect of the reinforcements, the study will compare contraceptive knowledge, attitudes, and behaviors of clients measured pre- and post-intervention in the comparison sites only, in the absence of the male engagement intervention. We further hypothesize that improvements will be incrementally greater in the four facilities exposed to the additional constructive male engagement intervention.
The study will include additional data collection and analyses to support secondary objectives.
- Services statistics will be tracked to assess changes in uptake and continuation of PMTCT services.
- The study will include a qualitative component to investigate condom use behaviors. Based on other investigations, it is anticipated that rates of self-reported condom use among C\&T clients will be high. To examine those behaviors more closely and to circumvent courtesy bias often associated with quantitative surveys, the study will conduct individual in-depth interviews with a subset of female and male C\&T clients reporting consistent condom use.
- The constructive male engagement intervention will comprise both community- and clinic-based components. To assess the effectiveness of the community-based men's workshops, the study will assess changes in knowledge, attitudes, and behaviors among men exposed to the community-based intervention by surveying them before and 4 months after community-level training is held. Interviews will assess knowledge and attitudes related to FP and HIV services (PMTCT in particular), with particular focus on gender norms supporting constructive male involvement. Interviews will also examine clients' recollection of services and messages received in the health center, along with their direct and indirect exposure to the community-based men's workshops.
- The effectiveness of the intervention components aimed at reinforcing the capacity of clinic-based providers to serve the family planning needs of HIV-positive individuals and to engage male partners constructively in FP decision making will be assessed in terms of its impact on C\&T clients. Specifically, interviews with C\&T clients will include questions about messages communicated by providers and service delivery practices reflecting successful implementation of the intervention components.
- Finally, the study will examine the resource requirements for adding each the interventions (reinforcement of FP and male involvement) into C\&T services. Based on costs of the piloted interventions, the study will arrive at an estimate of the cost of implementing these interventions at scale under the direction of the district management team.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic based intervention | Active comparator | Other: clinic based interventionbasic intervention is introduced, whereby HIV/AIDS providers are trained on contraception for HIV-positive women. They are charged with counseling C\&T clients on FP; offering condoms, pills and injectables; and referring clients for other FP methods |
| clinic and community based intervention | Experimental | Other: clinic and community based interventionThe basic intervention is introduced along with an intervention for constructive male engagement in HIV and FP services. This includes training of C\&T providers on gender-based influences on health behaviors; provision of couples' HIV testing and FP counseling services; and community-based education for men to promote gender equitable norms and male participation in health services. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- female participants
- attending pre-ART and ART services;
- non-pregnant women;
- age 18 to 45;
- sexually active with any type of partner within the past 3 months.
Key exclusion criteria (2 listed)
- For the post-intervention interviews, clients who initiated Care \& Treatment services in one of the intervention facilities less than 3 months prior will be excluded given insufficient exposure to the intervention.
- Clients unable to speak Runyankole, the dominant language in the region, will also be excluded
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 |
|---|---|---|
| clinic based interventioncounseling C\&T clients on FP; offering condoms, pills and injectables; and referring clients for other FP methods | Other | Clinic based intervention |
| clinic and community based interventionbasic intervention is introduced along with an intervention for constructive male engagement in HIV and FP services | Other | clinic and community based intervention |
Primary outcome
To assess the effectiveness of an intervention aimed at constructively engaging men in FP decision making
Time frame: 12 months
Dual method use among couples with at least one partner using C\&T services
5 secondary outcomes
To measure changes over time in uptake of Prong 3 PMTCT services, comparing facilities that are and are not exposed to the constructive male engagement intervention
Time frame: 6 months
To assess the effect of reinforcements introduced to enhance C&T providers' capacity to serve the FP needs of HIV-positive clients, as reflected in C&T clients' knowledge, attitudes, and behaviors related to FP.
Time frame: 12 months
To explore condom use dynamics and the factors favoring and discouraging consistent use by cohabiting couples
Time frame: 1 month
To evaluate men's knowledge and attitudes related to gender norms and FP and HIV services before and after participation in a 10-week community education and mobilization program.
Time frame: 10 months
To document the technical, human, and material resources required to implement the study interventions and to estimate the financial cost of implementation at scale.
Time frame: 12 months
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 9 Jan 2015.
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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.
Theresa Hoke, Ph.D., MPH principal investigator
FHI 360
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinic based intervention and clinic and community based intervention in people with HIV, run by FHI 360 at 7 sites 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 9 inclusion and 2 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 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. 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?
To assess the effectiveness of an intervention aimed at constructively engaging men in FP decision making (time frame: 12 months). 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 9 Jan 2015.