Trial Outcomes & Findings for Scientific Evaluation of Peer Education and STD Treatment to Reduce the Spread of HIV in Zimbabwe (NCT NCT00390949)
NCT ID: NCT00390949
Last Updated: 2024-11-22
Results Overview
Number of new infections occurring per 100 person-years of follow-up
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9454 participants
Primary outcome timeframe
3 years
Results posted on
2024-11-22
Participant Flow
Study participants were recruited from six pairs of sub-communities matched on socio-economic criteria
Participant milestones
| Measure |
Control Arm
Control communities were to receive standard Government services including basic syndromic STI management, condom distribution from health clinics and Zimbabwe National Family Planning Council outlets, homebased care, and limited HIV/AIDS-focussed IEC activities (e.g., occasional AIDS-awareness meetings and distribution of posters and leaflets). In addition, social marketing of male and female condoms would be provided through an ongoing national programme.
|
Intervention Arm
In addition to the standard-of-care services provided in the control arm, the intervention communities were to receive targeted and population-level activities to promote safer sexual behaviour and to improve treatment of STIs that facilitate HIV-1 transmission. The intervention strategies were to be implemented by two local nongovernmental organisations and the Zimbabwe Ministry of Health and Child Welfare through an integrated programme of community- and clinic-based activities. The programme design comprised three key components: (1) peer education and condom distribution amongst commercial sex workers and male clients at workplaces and in the general community, supported by income-generating projects; (2) strengthened syndromic management of STI services at local health centres; and (3) open days with HIV/AIDS IEC activities at health centres to promote safer sexual behaviour and to increase the uptake of local STI treatment services.
|
|---|---|---|
|
Overall Study
STARTED
|
4662
|
4792
|
|
Overall Study
COMPLETED
|
2564
|
2664
|
|
Overall Study
NOT COMPLETED
|
2098
|
2128
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Scientific Evaluation of Peer Education and STD Treatment to Reduce the Spread of HIV in Zimbabwe
Baseline characteristics by cohort
| Measure |
Control Arm
n=4662 Participants
Control communities were to receive standard Government services including basic syndromic STI management, condom distribution from health clinics and Zimbabwe National Family Planning Council outlets, homebased care, and limited HIV/AIDS-focussed IEC activities (e.g., occasional AIDS-awareness meetings and distribution of posters and leaflets). In addition, social marketing of male and female condoms would be provided through an ongoing national programme.
|
Intervention Arm
n=4792 Participants
In addition to the standard-of-care services provided in the control arm, the intervention communities were to receive targeted and population-level activities to promote safer sexual behaviour and to improve treatment of STIs that facilitate HIV-1 transmission. The intervention strategies were to be implemented by two local nongovernmental organisations and the Zimbabwe Ministry of Health and Child Welfare through an integrated programme of community- and clinic-based activities. The programme design comprised three key components: (1) peer education and condom distribution amongst commercial sex workers and male clients at workplaces and in the general community, supported by income-generating projects; (2) strengthened syndromic management of STI services at local health centres; and (3) open days with HIV/AIDS IEC activities at health centres to promote safer sexual behaviour and to increase the uptake of local STI treatment services.
|
Total
n=9454 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age group in years · Under 20
|
1138 Participants
n=39 Participants
|
1127 Participants
n=41 Participants
|
2265 Participants
n=35 Participants
|
|
Age, Customized
Age group in years · 20-24
|
1036 Participants
n=39 Participants
|
1095 Participants
n=41 Participants
|
2131 Participants
n=35 Participants
|
|
Age, Customized
Age group in years · 25-34
|
1338 Participants
n=39 Participants
|
1363 Participants
n=41 Participants
|
2701 Participants
n=35 Participants
|
|
Age, Customized
Age group in years · 35-44
|
955 Participants
n=39 Participants
|
1037 Participants
n=41 Participants
|
1992 Participants
n=35 Participants
|
|
Age, Customized
Age group in years · 45 and above
|
195 Participants
n=39 Participants
|
170 Participants
n=41 Participants
|
365 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
2502 Participants
n=39 Participants
|
2632 Participants
n=41 Participants
|
5134 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
2160 Participants
n=39 Participants
|
2160 Participants
n=41 Participants
|
4320 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4662 Participants
n=39 Participants
|
4792 Participants
n=41 Participants
|
9454 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
Zimbabwe
|
4662 participants
n=39 Participants
|
4792 participants
n=41 Participants
|
9454 participants
n=35 Participants
|
|
HIV prevalence
HIV positive
|
999 Participants
n=39 Participants
|
1172 Participants
n=41 Participants
|
2171 Participants
n=35 Participants
|
|
HIV prevalence
HIV negative
|
3663 Participants
n=39 Participants
|
3620 Participants
n=41 Participants
|
7283 Participants
n=35 Participants
|
|
More than 5 sexual partners in lifetime
|
999 Participants
n=39 Participants
|
1063 Participants
n=41 Participants
|
2062 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: General population
Number of new infections occurring per 100 person-years of follow-up
Outcome measures
| Measure |
Control Arm
n=2564 Participants
Control communities were to receive standard Government services including basic syndromic STI management, condom distribution from health clinics and Zimbabwe National Family Planning Council outlets, homebased care, and limited HIV/AIDS-focussed IEC activities (e.g., occasional AIDS-awareness meetings and distribution of posters and leaflets). In addition, social marketing of male and female condoms would be provided through an ongoing national programme.
|
Intervention Arm
n=2664 Participants
In addition to the standard-of-care services provided in the control arm, the intervention communities were to receive targeted and population-level activities to promote safer sexual behaviour and to improve treatment of STIs that facilitate HIV-1 transmission. The intervention strategies were to be implemented by two local nongovernmental organisations and the Zimbabwe Ministry of Health and Child Welfare through an integrated programme of community- and clinic-based activities. The programme design comprised three key components: (1) peer education and condom distribution amongst commercial sex workers and male clients at workplaces and in the general community, supported by income-generating projects; (2) strengthened syndromic management of STI services at local health centres; and (3) open days with HIV/AIDS IEC activities at health centres to promote safer sexual behaviour and to increase the uptake of local STI treatment services.
|
|---|---|---|
|
HIV Incidence at the Community Level
|
1.49 HIV infections per 100 person-years
Interval 1.18 to 1.8
|
2.04 HIV infections per 100 person-years
Interval 1.68 to 2.4
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Men and women who report having started sex
Percentage of sexually-experienced adults reporting genital ulcers
Outcome measures
| Measure |
Control Arm
n=2523 Participants
Control communities were to receive standard Government services including basic syndromic STI management, condom distribution from health clinics and Zimbabwe National Family Planning Council outlets, homebased care, and limited HIV/AIDS-focussed IEC activities (e.g., occasional AIDS-awareness meetings and distribution of posters and leaflets). In addition, social marketing of male and female condoms would be provided through an ongoing national programme.
|
Intervention Arm
n=2409 Participants
In addition to the standard-of-care services provided in the control arm, the intervention communities were to receive targeted and population-level activities to promote safer sexual behaviour and to improve treatment of STIs that facilitate HIV-1 transmission. The intervention strategies were to be implemented by two local nongovernmental organisations and the Zimbabwe Ministry of Health and Child Welfare through an integrated programme of community- and clinic-based activities. The programme design comprised three key components: (1) peer education and condom distribution amongst commercial sex workers and male clients at workplaces and in the general community, supported by income-generating projects; (2) strengthened syndromic management of STI services at local health centres; and (3) open days with HIV/AIDS IEC activities at health centres to promote safer sexual behaviour and to increase the uptake of local STI treatment services.
|
|---|---|---|
|
Self-reported Genital Ulcers
|
9.04 Percentage of sexually active adults
Interval 7.95 to 10.22
|
7.47 Percentage of sexually active adults
Interval 6.45 to 8.6
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Men and women who report having started sex
Percentage of sexually-experienced adults self-reporting urethral or genital discharge
Outcome measures
| Measure |
Control Arm
n=2528 Participants
Control communities were to receive standard Government services including basic syndromic STI management, condom distribution from health clinics and Zimbabwe National Family Planning Council outlets, homebased care, and limited HIV/AIDS-focussed IEC activities (e.g., occasional AIDS-awareness meetings and distribution of posters and leaflets). In addition, social marketing of male and female condoms would be provided through an ongoing national programme.
|
Intervention Arm
n=2418 Participants
In addition to the standard-of-care services provided in the control arm, the intervention communities were to receive targeted and population-level activities to promote safer sexual behaviour and to improve treatment of STIs that facilitate HIV-1 transmission. The intervention strategies were to be implemented by two local nongovernmental organisations and the Zimbabwe Ministry of Health and Child Welfare through an integrated programme of community- and clinic-based activities. The programme design comprised three key components: (1) peer education and condom distribution amongst commercial sex workers and male clients at workplaces and in the general community, supported by income-generating projects; (2) strengthened syndromic management of STI services at local health centres; and (3) open days with HIV/AIDS IEC activities at health centres to promote safer sexual behaviour and to increase the uptake of local STI treatment services.
|
|---|---|---|
|
Self-reported Urethral or Genital Discharge
|
11.91 Percentage of sexually experience adults
Interval 10.67 to 13.23
|
10.50 Percentage of sexually experience adults
Interval 9.31 to 11.8
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Men and women who report having started sex and STI symptoms in past year
Self-reported sexually transmitted infection treatment effectiveness based on self-reported cessation of symptoms
Outcome measures
| Measure |
Control Arm
n=278 Participants
Control communities were to receive standard Government services including basic syndromic STI management, condom distribution from health clinics and Zimbabwe National Family Planning Council outlets, homebased care, and limited HIV/AIDS-focussed IEC activities (e.g., occasional AIDS-awareness meetings and distribution of posters and leaflets). In addition, social marketing of male and female condoms would be provided through an ongoing national programme.
|
Intervention Arm
n=273 Participants
In addition to the standard-of-care services provided in the control arm, the intervention communities were to receive targeted and population-level activities to promote safer sexual behaviour and to improve treatment of STIs that facilitate HIV-1 transmission. The intervention strategies were to be implemented by two local nongovernmental organisations and the Zimbabwe Ministry of Health and Child Welfare through an integrated programme of community- and clinic-based activities. The programme design comprised three key components: (1) peer education and condom distribution amongst commercial sex workers and male clients at workplaces and in the general community, supported by income-generating projects; (2) strengthened syndromic management of STI services at local health centres; and (3) open days with HIV/AIDS IEC activities at health centres to promote safer sexual behaviour and to increase the uptake of local STI treatment services.
|
|---|---|---|
|
Percentage of Participants Reporting Cessation of Sexually Transmitted Infection Symptoms
|
71.58 Percentage of sexually experience adults
Interval 65.89 to 76.81
|
60.44 Percentage of sexually experience adults
Interval 54.37 to 66.28
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Men and women who report having started sex
Percentage of participants in the survey who report more than one casual partner in the past 3 years
Outcome measures
| Measure |
Control Arm
n=2447 Participants
Control communities were to receive standard Government services including basic syndromic STI management, condom distribution from health clinics and Zimbabwe National Family Planning Council outlets, homebased care, and limited HIV/AIDS-focussed IEC activities (e.g., occasional AIDS-awareness meetings and distribution of posters and leaflets). In addition, social marketing of male and female condoms would be provided through an ongoing national programme.
|
Intervention Arm
n=2302 Participants
In addition to the standard-of-care services provided in the control arm, the intervention communities were to receive targeted and population-level activities to promote safer sexual behaviour and to improve treatment of STIs that facilitate HIV-1 transmission. The intervention strategies were to be implemented by two local nongovernmental organisations and the Zimbabwe Ministry of Health and Child Welfare through an integrated programme of community- and clinic-based activities. The programme design comprised three key components: (1) peer education and condom distribution amongst commercial sex workers and male clients at workplaces and in the general community, supported by income-generating projects; (2) strengthened syndromic management of STI services at local health centres; and (3) open days with HIV/AIDS IEC activities at health centres to promote safer sexual behaviour and to increase the uptake of local STI treatment services.
|
|---|---|---|
|
Percentage of Participants Reporting More Than One Casual Partner in the Past 3 Years
|
14.59 Percentage of sexually experience adults
Interval 13.21 to 16.05
|
13.38 Percentage of sexually experience adults
Interval 12.01 to 14.84
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Adults in the general population followed up from baseline
Percentage of survey participants reporting having attended a peer-education activity or other intervention programme meeting
Outcome measures
| Measure |
Control Arm
n=2612 Participants
Control communities were to receive standard Government services including basic syndromic STI management, condom distribution from health clinics and Zimbabwe National Family Planning Council outlets, homebased care, and limited HIV/AIDS-focussed IEC activities (e.g., occasional AIDS-awareness meetings and distribution of posters and leaflets). In addition, social marketing of male and female condoms would be provided through an ongoing national programme.
|
Intervention Arm
n=2486 Participants
In addition to the standard-of-care services provided in the control arm, the intervention communities were to receive targeted and population-level activities to promote safer sexual behaviour and to improve treatment of STIs that facilitate HIV-1 transmission. The intervention strategies were to be implemented by two local nongovernmental organisations and the Zimbabwe Ministry of Health and Child Welfare through an integrated programme of community- and clinic-based activities. The programme design comprised three key components: (1) peer education and condom distribution amongst commercial sex workers and male clients at workplaces and in the general community, supported by income-generating projects; (2) strengthened syndromic management of STI services at local health centres; and (3) open days with HIV/AIDS IEC activities at health centres to promote safer sexual behaviour and to increase the uptake of local STI treatment services.
|
|---|---|---|
|
Percentage of Participants Attending a Peer Education or Other Programme Meeting
|
20.25 Percentage of adults
Interval 18.73 to 21.85
|
4.75 Percentage of adults
Interval 3.94 to 5.66
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Adults in the general population
Index calculated based on responses to a set of survey questions on knowledge about how HIV can be transmitted, factors increasing the risk of HIV transmission, signs and symptoms of HIV/AIDS, and the average durations of HIV infection and survival with AIDS at the time of the study (i.e. in the period prior to availability of antiretroviral treatment). Index scores could range between 0% and 100% with higher scores reflecting greater knowledge about HIV and AIDS.
Outcome measures
| Measure |
Control Arm
n=2683 Participants
Control communities were to receive standard Government services including basic syndromic STI management, condom distribution from health clinics and Zimbabwe National Family Planning Council outlets, homebased care, and limited HIV/AIDS-focussed IEC activities (e.g., occasional AIDS-awareness meetings and distribution of posters and leaflets). In addition, social marketing of male and female condoms would be provided through an ongoing national programme.
|
Intervention Arm
n=2590 Participants
In addition to the standard-of-care services provided in the control arm, the intervention communities were to receive targeted and population-level activities to promote safer sexual behaviour and to improve treatment of STIs that facilitate HIV-1 transmission. The intervention strategies were to be implemented by two local nongovernmental organisations and the Zimbabwe Ministry of Health and Child Welfare through an integrated programme of community- and clinic-based activities. The programme design comprised three key components: (1) peer education and condom distribution amongst commercial sex workers and male clients at workplaces and in the general community, supported by income-generating projects; (2) strengthened syndromic management of STI services at local health centres; and (3) open days with HIV/AIDS IEC activities at health centres to promote safer sexual behaviour and to increase the uptake of local STI treatment services.
|
|---|---|---|
|
Percentage of Participants Scoring 60% or Above on an Index of HIV/AIDS Knowledge
|
51.40 Percentage of adults
Interval 49.49 to 53.31
|
47.30 Percentage of adults
Interval 45.36 to 49.24
|
Adverse Events
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place